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Manager, US Regulatory Affairs – Medical Devices at Innomar Strategies Inc.

Manager, US Regulatory Affairs – Medical Devices

Innomar Strategies Inc. Full-Time

Are you looking to make a difference in a patient’s life?  At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference.  As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!



What you will be doing

As of October 18, 2021, AmerisourceBergen requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief you will be required to follow AmerisourceBergen’s policy and process to apply for an exemption/accommodation

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Co-ordinate and compile high quality regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects
  • Effectively prioritize, coordinate and complete multiple projects within established timeframes and budget.
  • Maintain and expand professional regulatory knowledge (primarily U.S. FDA, but also Health Canada) in order to provide effective consulting services

Other duties and responsibilities

  • Implement an agreed upon action plan to achieve timely approval of regulatory submissions which ensure compliance with applicable regulations, policy and guidance.
  • Participate in and support project teams
  • Identify client and dossier issues and develop effective strategies to address them consulting with others as needed.
  • Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with clients/agencies.
  • Responsible for the quality control of documents and / or data, as required.
  • Support of proposals to clients and other new business activities as needed.
  • Train or mentor others to build team expertise
  • Proactively improve business process and tools to expedite core services.
  • Ability to travel as necessary, passport required


What your background should look like 

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

  • B.Sc. (advanced degree preferred) in Life Sciences (Microbiology, Biology, Chemistry or Pharmacy preferred) or extensive equivalent experience and related training.
  • 3+ years experience with U.S. FDA medical device ( (510(k), PMA, IDE etc.) submissions
  • Experience with FDA agency meetings an asset
  • Certification in Regulatory Affairs (RAC) and /or prior consulting experience an asset.
  • 5 - 8 years Regulatory Affairs or related relevant experience within the health care products industry, or consulting

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

  • Strong working knowledge of FDA regulations, guidelines and policies
  • Excellent computer skills with training in current software applications (MS Office, Adobe Professional).
  • Excellent interpersonal, verbal and written communication skills.
  • Self-motivated and proactive
  • Effective organizational skills; attention to detail
  • Ability to consistently meet deadlines
  • Direct experience and working knowledge of a range of health care products
  • Excellent problem-solving skills; ability to resolve issues effectively and efficiently
  • Demonstrated ability to work in a cross-functional, multi-disciplinary team environment.

#LI-MG1



What AmerisourceBergen offers


We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.

Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.



Schedule

Full time

Equal Employment Opportunity



AmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

 

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