Regulatory Affairs associate
Reporting to the Director, Regulatory Affairs, the Regulatory Affairs Associate ensures the completion and revision of documents intended for regulatory authorities in order to receive marketing approval in several countries. He participates in the drafting and revision of reports and other documents that may be reviewed by external agencies. He has the knowledge and methods necessary to produce well-written and structured documentation. He has the necessary knowledge to understand the scientific concepts of orthopedic implants.
- Gathers and synthesizes information necessary for the development of regulatory dossiers in accordance with U.S., Canadian and European regulatory standards in the field of orthopedic medical devices;
- Plans, writes and reviews texts and reports to ensure the regulatory compliance of the company;
- Writes and / or revises documents to explain clearly and concisely the results of studies and the principle of operation of the products;
- Prepares regulatory files for the marketing of the company's products;
- Provides regulatory oversight of approved products. Keeps files up to date; ensures the regulatory compliance of these products.
- Any other responsibilities deemed appropriate by the Director, Regulatory Affairs
- Bilingualism required, both orally and in written (English and French) - Full proficiency in written French and English.
- Experience in writing documents in English with scientific or technical content.
- Ability to meet tight deadlines and work under pressure.
- Ability to adapt to change and flexibility.
- Ability to run multiple projects in parallel
- Be familiar with several types of regulatory submissions for new products
Education: Bachelor's degree or Master's degree in Life Science or Engineering.
Experience: Two to five years of experience in regulatory affairs in the medical device industry or a related field.