Regulatory Affairs Manager

3 weeks ago


PointeClaire, Quebec, Canada AMD Medicom inc. Full time
Unlock Your Potential as a Pre-Market Regulatory Affairs Manager

Are you a seasoned professional with a passion for regulatory affairs and a drive to succeed? Do you thrive in fast-paced environments and enjoy working with cross-functional teams? If so, we invite you to explore this exciting opportunity to join our team as a Pre-Market Regulatory Affairs Manager at AMD Medicom inc.

About the Role

As a key member of our regulatory team, you will play a critical role in ensuring the success of our new product offerings by developing and executing the pre-market regulatory strategy and tactical plans. You will work closely with North American and European health authorities, as well as internal stakeholders, to ensure the achievement of product commercialization priorities and overall business objectives.

Key Responsibilities
  • Develop and execute the pre-market regulatory strategy and tactical plans.
  • Assist marketing and commercial teams to identify product portfolio gaps/opportunities, support product positioning.
  • Support regulatory assessment of future product offering opportunities during Merger and Acquisition (M&A) process.
  • Organize project activities and deliverables.
  • Lead the implementation of process improvements/tools.
  • Support the smooth knowledge transfer and transition of new products to the Post-Market Regulatory Compliance team.
  • Ensure your team's deliverables are met timely with accuracy.
  • Ensure your team lives Medicom's core values of Teamwork, Accountability, Customer Centricity and Empathy; be an example to the team.
  • Coach, mentor and develop team members.
Requirements
  • Bachelor's degree in engineering, life sciences, quality/regulatory or related technical discipline.
  • Minimum of 8 years progressive experience in Regulatory Affairs environment, preferably in medical devices.
  • Minimum of 5 years of experience in management of personnel and enabling a positive company culture.
  • Strong experience and demonstrated success in dealing with regulatory agencies (Canada, US, Europe) for regulatory approvals of new and innovative products.
  • Knowledge of regulatory requirements for medical devices (primary focus), natural health products and drug products (Canada, US and Europe).
  • Bilingualism (French and English).
  • Strong communication skills with the ability to interact and influence.
  • Solid business acumen.
  • Demonstrated flexibility and creativity with a solutions-oriented approach.
What We Offer
  • Competitive salary.
  • Comprehensive insurance program including EAP and telemedicine for you and your family.
  • Pension plan with company matching.
  • Possibility of a hybrid work schedule, with home internet and office expense allowance.
  • A lot of training, coaching and professional development opportunities.
  • Fun work atmosphere, an active social committee that organizes fun activities such as sports, BBQs, family events and more.
Equal Opportunity Employer

AMD Medicom inc. is an equal opportunity employer. We consider all applicants without regard to age, gender, gender identity or expression, sexual orientation, race, ethnic or national origin, religious beliefs, sex (including pregnancy and breastfeeding), disability or marital or family status. We welcome applications from all qualified individuals and encourage Indigenous persons, persons of color, LGBTQ+ and gender-nonconforming persons, persons with disabilities, women, and members of any other marginalized group.



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