Regulatory Affairs Specialist – Medical Devices – Mchenry, IL

ESSENTIAL FUNCTIONS

  • Consultancy and support of project teams during the development of new products and the product lifecycle in terms of questions in regards to risk management, products safety licensing as well as standards and guidance documents
  • Advise project team members on data and information required for successful license applications and coordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission
  • Independent review of technical documentation according to specific international laws and guidance documents relevant for medical devices
  • Establishment and maintenance of the Regulatory Process related documentation within the product lifecycle
  • Maintenance of the product licenses for the relevant markets
  • Responsible for routine operations including, but not limited to, label reviews, marketing literature reviews, and regulatory support for customers, sales channel and internal personnel.
  • Researches regulations, and obtains regulatory updates from professional organizations and government agencies
  • Works on assigned projects as allocated by the Regulatory Affairs Manager
  • Researches Federal, State and local regulations governing the manufacture, promotion, distribution, disposal and export of company products
  • Communicates current and upcoming regulations to appropriate internal and sales channel personnel, when necessary
  • Maintains an understanding of the documentation required to support the import and export of products, parts and accessories
  • Responds to vendor, sales agent, and customer inquiries regarding regulatory issues
  • Attends internal meetings to represent the Regulatory Affairs Department
  • Reviews marketing literature to ensure regulatory compliance
  • Reviews labeling for conformance with applicable regulations (FDA, FTC, NIST, etc), edits and approves such labeling as necessary and when designated
  • Reviews Design History Files and Technical Files of products for completeness and accuracy, when required
  • Complies with all federal, state, and local laws and regulations
  • Follows all Company rules and regulations, including health and safety rules
  • Successfully interacts with employees at all levels
  • Regular, reliable performance of all job duties
  • Travel as may be required to meet business expectations
  • Performs all other duties as assigned or as may be required from time to time

EDUCATION and CRITICAL SKILLS/EXPERIENCE

  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
  • Minimum 3-5 years regulatory affairs experience required

  • Regulatory Affairs Certification (RAC) preferred
  • Knowledgeable of 21 CFR 801 and, 820
  • Knowledgeable of FDA guidelines and ISO standards for Medical Devices
  • Knowledgeable of foreign regulations for medical devices
  • Knowledge of technical standards (e.g. IEC 60601, IEC 62366)
  • Must possess accuracy; strong attention to detail; solid written and oral communication skills; ability to prioritize projects and work independently; and excellent organizational skills
  • Ability to read and understand complex technical, legislative and regulation information and make independent decisions
  • Excellent verbal and written communication skills
  • Excellent ability to organize and manage information
  • Ability to manage multiple conflicting priorities
  • Experience working in an environment with global objectives

LANGUAGE/REASONING SKILLS

  • Must be able to read, understand and communicate in English
  • Apply principles of logical thinking to solve practical problems

PHYSICAL DEMANDS 

  • Travel  5% of the time, including occasional international travel
  • Must be able to occasionally lift and/or move up to 10 pounds

ENVIRONMENTAL CONDITIONS 

  • Indoors, average office environment with little exposure to excessive noise, dust, or temperature changes
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Key Account Manager – Breastfeeding and Enteral Feeding Products – Portland – Portland, OR

Sales Representative – Breastfeeding​ and Enteral Feeding Products

JOB TITLE: Sales Consultant
 
Compensation Profile:
Base: $80K – $85K
Commission at plan: $40K+ 
First Year at Plan: 
$125K+
Full Medical / Dental
Pension
401K 

Travel – 50% 

 
ESSENTIAL FUNCTIONS

  • Field sales coverage in a specified geographical area selling company Breastfeeding and Enteral Feeding products to hospital accounts to include Mother-Baby area and Neonatal Intensive Care Unit. 
  • Learning:
    • Maintain the highest degree of product knowledge through continuing study, including characteristics, quality, engineering, competitive advantages, customer applications, features, benefits and proof sources
  • Planning:
    • Follows sound time and territory management techniques
    • Quarterly defines customers to be visited and maintains call frequency standards
    • Plans account, travel and call strategies
    • Concentrates on major hospital accounts, top birthing hospitals with Level II and Level III NICU’s and Children’s Hospitals
    • Preplans sales calls; reviews background information, sets call objectives and defines selling strategies
    • Submits regular objectives, action plans and sales projections
  • Selling:
    • Utilizes professional selling skills to solicit sales of company products
    • Seeks increased volume by selling established customers a greater percentage of their needs or other products they are not currently buying from us, targeting enteral feeding as a primary product line to sell into the NICU
    • Seeks new customers, either known target accounts or new business found by prospecting
    • Strives on a continuing basis to achieve, maintain and expand contacts within customer organizations
    • Makes contacts at all levels and with all groups, which might influence current and future buying decision, these contacts include NICU Manager, Clinical Nurse Educators,  Clinical Nurse Specialists, Neonatologists, Pharmacy, Mother Baby Manager, Lactation, Infection Control and Supply Chain,
  • Servicing and follow-up
    • Provides field sales service to all accounts in assigned territory
    • Service includes solving problems, assisting customers and ensuring their satisfaction with our products, including technical advice on the use of products, delivery considerations, quality control, invoicing, etc.
    • Provides these services personally where feasible, or initiates and coordinates action through appropriate company support personnel
    • Follows up to make sure customer requests/problems are satisfactorily resolved
  • Communications and reporting:
    • Submits required reports promptly and legibly
    • Completes and submits expense reports monthly or as specified by Regional Manager
    • Communicates with Regional Manager as needed and coordinates with team specialists for trials and implementations of new products
    • Develops customer communications such as presentations, bids, quotes, etc., as needed
  • Field surveillance:
    • Serves as the eyes and ears of the company within assigned territory by observing, appraising and reporting on competitive activities, price developments, customer plans, product trends, new product potentials, market trends and related matters
    • Complies with all federal, state, and local laws and regulations
    • Follows all Company rules and regulations, including health and safety rules
    • Successfully interacts with employees at all levels
    • Regular, reliable performance of all job duties
    • Travel as may be required to meet business and customer expectations
    • Performs all other duties as assigned or as may be required from time to time

 
EDUCATION and CRITICAL SKILLS/EXPERIENCE

  • Bachelor’s degree in Business, Marketing or related field is required
  • Minimum five years’ experience in Medical Sales, selling to hospitals with a clear understanding of how to navigate within the hospital environment calling on multiple call points 
  • Excellent verbal and written communication skills
  • Ability to manage multiple conflicting priorities
  • Experience working in an environment with global objectives

 
LANGUAGE/REASONING SKILLS

  • Must be able to read, understand and communicate in English
  • Apply principles of logical thinking to solve practical problems

 
PHYSICAL DEMANDS  

  • Travel up to 80% of the time
  • Travel based on  geographic area of territory and requirements of the Regional Manager to protect and drive business

 
ENVIRONMENTAL CONDITIONS  

  • While performing the duties of this job, the employee is often exposed to road travel and clinical environments, such as hospitals, physician offices, and clinics

 
 
The employee is expected to efficiently and effectively perform all of the above tasks.  
 
Company will make reasonable accommodations in compliance with the Americans with Disabilities Act.
 
This job description is subject to change at any time. Company has the right to assign or reassign duties and responsibilities to this job as business needs require.  
 

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Key Account Manager – Breastfeeding and Enteral Feeding Products – Seattle – Seattle, WA

Sales Representative – Breastfeeding​ and Enteral Feeding Products

JOB TITLE: Sales Consultant
 
Compensation Profile:
Base: $80K – $85K
Commission at plan: $40K+ 
First Year at Plan: 
$125K+
Full Medical / Dental
Pension
401K 

Travel – 50% 

 
ESSENTIAL FUNCTIONS

  • Field sales coverage in a specified geographical area selling company Breastfeeding and Enteral Feeding products to hospital accounts to include Mother-Baby area and Neonatal Intensive Care Unit. 
  • Learning:
    • Maintain the highest degree of product knowledge through continuing study, including characteristics, quality, engineering, competitive advantages, customer applications, features, benefits and proof sources
  • Planning:
    • Follows sound time and territory management techniques
    • Quarterly defines customers to be visited and maintains call frequency standards
    • Plans account, travel and call strategies
    • Concentrates on major hospital accounts, top birthing hospitals with Level II and Level III NICU’s and Children’s Hospitals
    • Preplans sales calls; reviews background information, sets call objectives and defines selling strategies
    • Submits regular objectives, action plans and sales projections
  • Selling:
    • Utilizes professional selling skills to solicit sales of company products
    • Seeks increased volume by selling established customers a greater percentage of their needs or other products they are not currently buying from us, targeting enteral feeding as a primary product line to sell into the NICU
    • Seeks new customers, either known target accounts or new business found by prospecting
    • Strives on a continuing basis to achieve, maintain and expand contacts within customer organizations
    • Makes contacts at all levels and with all groups, which might influence current and future buying decision, these contacts include NICU Manager, Clinical Nurse Educators,  Clinical Nurse Specialists, Neonatologists, Pharmacy, Mother Baby Manager, Lactation, Infection Control and Supply Chain,
  • Servicing and follow-up
    • Provides field sales service to all accounts in assigned territory
    • Service includes solving problems, assisting customers and ensuring their satisfaction with our products, including technical advice on the use of products, delivery considerations, quality control, invoicing, etc.
    • Provides these services personally where feasible, or initiates and coordinates action through appropriate company support personnel
    • Follows up to make sure customer requests/problems are satisfactorily resolved
  • Communications and reporting:
    • Submits required reports promptly and legibly
    • Completes and submits expense reports monthly or as specified by Regional Manager
    • Communicates with Regional Manager as needed and coordinates with team specialists for trials and implementations of new products
    • Develops customer communications such as presentations, bids, quotes, etc., as needed
  • Field surveillance:
    • Serves as the eyes and ears of the company within assigned territory by observing, appraising and reporting on competitive activities, price developments, customer plans, product trends, new product potentials, market trends and related matters
    • Complies with all federal, state, and local laws and regulations
    • Follows all Company rules and regulations, including health and safety rules
    • Successfully interacts with employees at all levels
    • Regular, reliable performance of all job duties
    • Travel as may be required to meet business and customer expectations
    • Performs all other duties as assigned or as may be required from time to time

 
EDUCATION and CRITICAL SKILLS/EXPERIENCE

  • Bachelor’s degree in Business, Marketing or related field is required
  • Minimum five years’ experience in Medical Sales, selling to hospitals with a clear understanding of how to navigate within the hospital environment calling on multiple call points 
  • Excellent verbal and written communication skills
  • Ability to manage multiple conflicting priorities
  • Experience working in an environment with global objectives

 
LANGUAGE/REASONING SKILLS

  • Must be able to read, understand and communicate in English
  • Apply principles of logical thinking to solve practical problems

 
PHYSICAL DEMANDS  

  • Travel up to 80% of the time
  • Travel based on  geographic area of territory and requirements of the Regional Manager to protect and drive business

 
ENVIRONMENTAL CONDITIONS  

  • While performing the duties of this job, the employee is often exposed to road travel and clinical environments, such as hospitals, physician offices, and clinics

 
 
The employee is expected to efficiently and effectively perform all of the above tasks.  
 
Company will make reasonable accommodations in compliance with the Americans with Disabilities Act.
 
This job description is subject to change at any time. Company has the right to assign or reassign duties and responsibilities to this job as business needs require.  
 

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Clinical Solutions Specialist – Los Angeles, CA

We have an immediate opening working as a Clinical Solutions Specialist for a leading manufacturer in the wound care space. 

This role involves traveling frequently across the assigned territory to assist in business development, sales presentations, clinical trainings, and more. Our client is looking for future leaders as this role has a high likelihood of advancement within the organization. 

Base: $110,000-$120,000
Incentive Comp: $20,000
OTE: $130,000+
Company Car
401K
Full Medical, Dental, Vision

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Lead Sales Analyst – Manville, NJ

We have an immediate opening for a Lead Data Analyst over Sales Force Effectiveness within a Medical Device company’s Wound Care Division.  This position would have full responsibility over Dashboards, Power AI, and analytics for their wound care business.

 

Ideally, we would like to have the candidate based near the Sommerville, NJ area to be able to commute into office when needed.  However, we would be open to remote candidates if they come from a competitor and have experience working within the wound care space.

 

Compensation Profile: 

Base Salary: $100,000+ (negotiable)

Bonus: 8% of base

Full Medical/Dental/Vision

401K

 

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Electrotherapy Sales Representative – Chicago – Chicago, IL

Position Summary 
The Account Manager is responsible for the promotion and sale of company products to qualified customers.

The Account Manager represents company products exclusively and receives a base salary, monthly commission, expense reimbursement, and health & welfare benefits.

Compensation Profile:
Base Salary of 72,000 per year or 6,000 per month
Commissions begin after the Account manager reaches $23,000 in any given month

  • The commission at below 90% of quota is 7% of expected collections over $23,000
  • The commission at 90% to 100% of quota is 10% of expected collections over $23,000
  • The commission at 100% to 110% % of quota is 13% of expected collections over $23,000
  • The commission at 110% or greater of quota is 16% of expected collections over $23,000

Key Responsibilities 

  • Manages account relationships in defined Accounts;
  • Assists in management of Field Service Representatives as business dictates;
  • Conducts business which is compliant with regulations and contracts covering the rental and/or sale of company products and services;
  • Instructs patients, health care providers and staff on the use of company products;
  • Ensures all required order information is submitted correctly to home office;
  • Utilizes CRM to manage and document all Prospecting, Sales Process, Account Updates, Patient Instruction, Administrative and Travel activities;
  • Implements marketing and product programs, as assigned;
  • Completes all training, as assigned;
  • Manages inventory of assigned company products consistent with Company policy and procedures;
  • Attends local/regional meetings, exhibits and additional training, as assigned.

Experience / Qualifications

  • College degree or equivalent combination of education and experience;
    • VA/DOD sales experience a plus
    • U.S Veteran/Armed Forces Reserve a plus
    • Workers Compensation or Personal Injury Protection experience a plus
  • Proven ability to manage a defined sales account(s);
  • Maintains solid relationships with a focus on exceptional service;
  • Proven ability to promote and detail complex/innovative medical technologies;
  • Proven success in presenting new products using effective sales processes and tools;
  • Strong knowledge of key influencers and decision-makers in a medical clinic or hospital setting;
  • Ability to develop, maintain and nurture effective working relationships within assigned accounts and territories; 
  • Highly organized, detail-oriented, and possesses the highest level of integrity;
  • Strong communication, presentation and interpersonal skills;
  • Proficient in the use of PC software applications including Microsoft Office and CRM; Salesforce.com a plus;
  • Ability to independently manage tasks and set priorities;
  • Maintains a valid Driver’s license and current automobile insurance.
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Sales Representative – Chronic Wound Care – Memphis – Memphis, TN

About the Role:
Reporting to the Regional Sales Manager, you will be responsible for driving the commercial success of the client’s best in class portfolio of advanced wound care products within a defined geographic area. You understand the importance of working with a team and will foster team effectiveness and accomplishment of goals by sharing knowledge, experience, and information to optimize business strategies and drive overall sales within the territory.

Compensation Profile:
Base Salary: $73,000
Commission: $72,000 + at plan incentive target (uncapped, can exceed the IC target).
Company Car
Full Medical / Dental benefits and 401K
  
Key Duties and Responsibilities:

  • Promote and sell portfolio of advanced wound products and understand competitive landscape to achieve sales results, quotas/targets and profitability goals
  • Develop new target accounts, establish new business and increase sales of current accounts
  • Develop and maintain action plans (i.e., weekly, monthly, quarterly, yearly) by analyzing territory performance, sales and reports to identify the needs of specific accounts and discuss issues with Regional Sales Manager to help the organization achieve its annual sales goals. Identify, prioritize, pull-through, and close opportunities.
  • Ensure effective utilization of the products by all trained HCPs within assigned territory
  • Network and build relationships across multiple care settings (i.e. OR, Nursing Units, Physician Offices, Care Coordinators, Cath Lab, L&D, etc.), and use information gathered to build territory strategy.
  • Maintains thorough knowledge and capabilities of the Company’s products, channels and methods of distribution
  • Demonstrate a clear understanding of clinical evidence and articulate our evidence-based value proposition
  • Demonstrates clinical understanding of targeted surgical procedures
  • Optimize the utilization of educational and KOL events (i.e. Examples are Trade Shows, Local Presentation at OR Department Meetings, Educational Meals)
  • Develop and cultivate KOL relationships
  • Keeps regional manager informed of territory progress on a regular basis
  • Undertakes effective calendar planning and time management skills
  • Attend national, regional, and local meetings as required. Represent the company in a professional manner at scheduled meetings
  • Adheres to T&E Travel Policy, Company’s compliance policy and Standards of Business Conduct & Ethics including relevant industry Codes of Practice
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Sales Representative – Post Acute Wound Care – Boston, MA – Boston, MA

About the Role:
Reporting to the Regional Sales Manager, you will be responsible for driving the commercial success of the client’s best in class portfolio of advanced wound care products within a defined geographic area. You understand the importance of working with a team and will foster team effectiveness and accomplishment of goals by sharing knowledge, experience, and information to optimize business strategies and drive overall sales within the territory.

Compensation Profile:
Base Salary: $72,950
Commission: $70,050 + at plan incentive target (uncapped, can exceed the IC target).
Company Car
Full Medical / Dental benefits and 401K
  
Key Duties and Responsibilities:

  • Promote and sell portfolio of advanced wound products and understand competitive landscape to achieve sales results, quotas/targets and profitability goals
  • Develop new target accounts, establish new business and increase sales of current accounts
  • Develop and maintain action plans (i.e., weekly, monthly, quarterly, yearly) by analyzing territory performance, sales and reports to identify the needs of specific accounts and discuss issues with Regional Sales Manager to help the organization achieve its annual sales goals. Identify, prioritize, pull-through, and close opportunities.
  • Ensure effective utilization of the products by all trained HCPs within assigned territory
  • Network and build relationships across multiple care settings (i.e. OR, Nursing Units, Physician Offices, Care Coordinators, Cath Lab, L&D, etc.), and use information gathered to build territory strategy.
  • Maintains thorough knowledge and capabilities of the Company’s products, channels and methods of distribution
  • Demonstrate a clear understanding of clinical evidence and articulate our evidence-based value proposition
  • Demonstrates clinical understanding of targeted surgical procedures
  • Optimize the utilization of educational and KOL events (i.e. Examples are Trade Shows, Local Presentation at OR Department Meetings, Educational Meals)
  • Develop and cultivate KOL relationships
  • Keeps regional manager informed of territory progress on a regular basis
  • Undertakes effective calendar planning and time management skills
  • Attend national, regional, and local meetings as required. Represent the company in a professional manner at scheduled meetings
  • Adheres to T&E Travel Policy, Company’s compliance policy and Standards of Business Conduct & Ethics including relevant industry Codes of Practice
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