POSITION DESCRIPTION

FOP CONSULTANTS is looking for specialists in regulatory affairs at the senior level motivated to deliver on mandates for its clients in the medical device sector. The mandate is to define the regulatory strategy for medical devices and prepare submissions to Health Canada, the FDA and notified bodies and to assess changes, manage incidents and recalls, and maintain licences through regulatory intelligence. The senior scope is further to define the regulatory strategy and the approval timeline and to mentor intermediate consultants and review their submissions.

KEY RESPONSIBILITIES

- Define the classification and regulatory strategy for medical devices.
- Prepare and submit licensing applications (Health Canada), 510(k), De Novo or PMA.
- Build technical files for CE marking in accordance with the EU MDR.
- Assess the regulatory impact of design or manufacturing changes.
- Manage incident reports and recalls.
- Review labelling and instructions for use.
- Ensure regulatory intelligence and the maintenance of licences.
- Define the regulatory strategy and the approval timeline.
- Mentor intermediate consultants and review their submissions.
- Lead exchanges with Health Canada, the FDA and foreign authorities.

CANDIDATE PROFILE

- Bachelor’s or Master’s degree in sciences (Medical Technology, Chemistry, Biochemistry, Pharmacology, etc),



in biomedical engineering or any other related discipline.
- Minimum ten (10) years of industry experience.
- Eight (08) to fifteen (15) years of experience as a Specialist in Regulatory Affairs.
- Sector standards: ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR 2017/745, MDSAP.
- Tools and systems: MS Office suite, Veeva Vault RIM, eCTD, regulatory databases.
- Hold one of the following certifications: RAC (RAPS), regulatory affairs certification.
- The following are considered assets: ASQ CQA, PMP, intellectual property training.
- Experience in Canadian public or private organizations.
- Language: French and English

WORK MODE

- Remote, Hybrid, In office

WHAT WE OFFER

At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:

- Competitive compensation that reflects your expertise;
- Complete protection through our group insurance plans;
- Professional liability insurance so you can practise with confidence;
- Remote-work flexibility, based on client needs;
- 3 weeks of vacation to recharge;
- 3 paid sick days, to take care of yourself;
- A monthly allowance for your transportation costs;
- Real opportunities for advancement within the organization;
- Ongoing access to training to grow your skills.

📌 specialists in regulatory affairs (Sr.) (Quebec City)
🏢 FOP Experts Conseils
📍 Quebec City