Regulatory Affairs Specialist - Medical Device - CDI 100%

Position Description:
Supporting the Regulatory Affairs department in ensuring compliance with regulatory frameworks governing product registration, submission, distribution, and post-market surveillance of medical devices across different market jurisdictions, primarily EU and US.

Reports to:
Senior Regulatory Affairs Specialist

Key responsibilities and accountabilities
• Contribute to multidisciplinary teams and communicate regulatory requirements effectively.
• Assist in preparing regulatory submissions for various regions.
• Monitor and relay the impact of global regulatory changes.
• Support the preparation of documents for:
o Audits.
o Clinical studies
o Replies to regulatory stakeholders (NCAs NB, FDA)
• Evaluate labeling and marketing materials for compliance.

Specific responsibilities
Regulatory Submissions
• Prepare and compile necessary documentation for regulatory submissions in various jurisdictions.
• Ensure compliance with relevant regulatory standards and guidelines.
• Maintain communication with regulatory authorities to facilitate submissions and approvals.
Post-Market Surveillance
• Update of systematic literature or database reviews.
• Monitor and report safety events in accordance with regulatory requirements.

Quality Management Systems (QMS)
• Maintain and update regulatory processes within the QMS framework.
• Participate in regulatory watch activities to identify and address changes in regulations.
• Engage in risk management activities and ensure compliance with applicable standards.
• Actively contribute to the improvement of the organization by proposing and implementing innovative solutions.

Knowledge, skills and abilities
Analytical skills
• Rigorous attention to detail.
• Strong organizational skill
• Ability to mobilize multidisciplinary knowledge and provide structured solutions to regulatory questions
• Ability to identify relevant sources of information to answer regulatory questions.
• Proactive problem-solving skills and a continuous improvement mindset.
Technical skills
• Strong skills in MS Word and Excel
• Excellent verbal and written communication skills in English and French.
Specific skills
• Enthusiasm for continuous learning and staying updated with evolving regulatory requirements and technological advancements.
• Understanding the interplay of regulatory documentation throughout the lifecycle of medical device development, marketing, and post-market maintenance.
• Demonstrated initiative in identifying and implementing process improvements.

Education and experience
Minimum of a Master's Degree in a scientific field such as Science, Pharmacy, or Engineering.
minimum 4 years of experience working with medical devices and their associated regulations.