Pre-Market Regulatory Affairs Manager - Pointe-Claire, Canada - AMD Medicom inc.

Description

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 manager you will contribute to the success of Medicom' s new product offerings by delivering the regulatory strategy and regulatory plans throughout the design and development process of new products. With your team you will ensure the achievement of product commercialization priorities and overall business objectives.

You will work closely with North American and European health authorities as well as internal stakeholders throughout Medicom Group and ensure strong work relationships critical to our success.

What you will do

Strategy/Business Focus (70%):

• 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.

Operational/Compliance (20%)

• 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.

People (10%)

• 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.

What you will bring

• 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

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 and apply today