Position Description
We are seeking a dedicated professional to support our Regulatory Affairs department in ensuring compliance with the regulatory frameworks governing product registration, submission, distribution, and post-market surveillance of medical devices across various market jurisdictions, primarily in the 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:
- Audits
- Clinical studies
- 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 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 skills.
- 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
A minimum of a Master's Degree in a scientific field such as Science, Pharmacy, or Engineering, along with at least 4 years of experience working with medical devices and their associated regulations.
Application Process
Apply online using the form below. Only applications matching the job profile will be considered.