Regulatory Affairs Manager

2 months ago

PointeClaire, Quebec, Canada AMD Medicom inc. Full time
Job Title: Pre-Market Regulatory Affairs Manager

We are seeking a highly skilled Pre-Market Regulatory Affairs Manager to join our team at AMD Medicom inc. This role will be responsible for developing and executing the pre-market regulatory strategy and tactical plans for our new product offerings.

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

Medicom 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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