Pre-Market Regulatory Affairs Specialist

Why join our team?

Think you have what it takes to work in an organization where creativity, drive and ambition are valued while integrity motivates everything we do?

Medicom has been in business for over 35 years, and it has kept its entrepreneurial mindset. Working with us, you will have the opportunity to get involved, have an impact, and contribute to the company’s continued growth.

We live by our values every day, focussing on customer satisfaction while ensuring teamwork, accountability, and empathy in everything we do.

Our team loves challenges and a fast-paced environment. You will have the flexibility to manage work and a personal life, as well as your own personal well-being.

We offer an attractive compensation package with benefits.

The Opportunity

As Pre-Market Regulatory Affairs specialist you will contribute to the success of Medicom’ s new product offerings by developing / executing the regulatory strategy and regulatory tactical plans throughout the design and development process as well as by ensuring the timely and successful registration of new products.

Your active participation in cross-functional teams as well as developing a close work relationship with health authorities (US, Canada, Europe) and internal stakeholders will be critical to your success.

What you will do

• Develop and execute the pre-market regulatory strategy and tactical plans.
• Provide strategic regulatory input throughout the design control process of medical devices.
• Prepare the technical file / technical file summaries for the new products as per US, Canada and European requirements.
• Communicate promptly to internal stakeholders any product-related risks as well as any changes in regulations with respect to new product or line-extension offerings.
• Participate in projects involving process improvements / tools.
• Support the creation of technical production specifications and similar / related controlled technical product documentation.

What you will bring

• Bachelor’s degree in engineering, life sciences, quality / regulatory or related technical discipline.
• Minimum of 2 years experience in Regulatory Affairs in a GMP (Good Manufacturing Practices) environment, preferably in medical devices.
• Knowledge of regulatory requirements for medical devices (primary focus), natural health products and drug products (Canada, US and Europe) and experience in dealing with regulatory agencies.
• Experience in project management and coordination of multiple parallel tasks and projects within defined and / or tight timelines.
• Bilingualism (French and English).
• Strategic skills, risk-based critical thinking, and analytical skills and a results-driven approach.
• Strong communication skills with the ability to interact and influence.

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

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.

If you are energetic, committed to making a difference and love challenges, we would love to hear from you. Visit our website at https : / / medicom.

com / en ca / careers / and apply today!