Specialist/Project Manager, regulatory affairs

Brief description of the position :

In order to meet the needs of our customers in the Medical Devices sector, we are looking for regulatory affairs consultants to carry out various mandates. The main missions would be to support all of the different departments in their regulatory requirements process, participate in staff training regarding regulatory instructions, write documents for the regulations authorities and collaborate on any project involved in medical device regulation.

Main responsibilities :

Without limitation, the main tasks involve:

• Manage project related to the medical device regulations;
• Review and write documents for the submission of the regulation’s authorities;
• Ensure regulatory section is taken into account in every aspect of a project;
• Proceed to regulatory surveillance to be aware of any changing in order to reduce non conformity risks;
• Write the standard operating procedures (SOPs) related to regulations;
• Train or participate to the training of the personnel in charge of regulatory process;
• Support by your technical expertise the less experienced personnel;
• Participate to the weekly or monthly meetings about the regulatory cases;
• Provide solutions to problems encountered and perform all tasks relevant to the mandate;

Qualifications :

• Bachelor’s or Master’s degree in sciences (Medical Technology, Chemistry, Biochemistry, Pharmacology, etc), in biomedical engineering or any other related discipline;
• 1 (one) to 10 (ten) years of experience in medical device or pharmaceutical industries;
• Strong project management skills (an asset);
• Experience in regulatory affairs in medical device or pharmaceutical industries (an asset);
• Proven knowledge of ISO 13485 Regulation;
• Proven knowledge of the medical device classes: I, IIa, IIb et III;
• Proven knowledge of Health Canada and FDA Regulations;
• Writing/oral communication skills, English and French;
• Perfect bilingualism (an asset);
• Valid class 5 driver’s license (an asset);
• Mobility, willing to travel (an asset).

Personal skills :

• Leadership;
• Rigor et discipline;
• (Organize), able to manage several projects;
• Analytical and critical mindset;
• Perseverance;
• Humility.

What we offer :

In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:

• Competitive wages;
• Group insurance;
• Professional insurance;
• Remote work, according to the customer needs;
• Vacations: 3 weeks;
• Paid sick leave: 3 days;
• Monthly transportation fees;
• Career advancement opportunity;
• Continuing education.