Quality Assurance & Regulatory Affairs (QARA) Lead

In this role, the QARA Lead will supervise and assure compliance of products, processes and operations with the applicable regulations, standards and quality system. This includes managing regulatory compliance processes and ensuring that products meet legal and safety requirements as well as communication with regulatory authorities and IRBs or ethiccommittees.

Regardless of role or team, we look for candidates with positive energy as well as the ability to independently orient themselves in an unstructured environment and follow through on problems that need to be solved.

Role responsibilities:

• Ensure compliance throughout the site by preparing and reviewing quality system documents, actively participating in the design control process, including design reviews, compliance audits, ensuring subcontract regulatory requirements are met, being aware of future regulations and taking proactive measures, and ensuring appropriate understanding of regulatory requirements throughout the company.
• Propose and execute the regulatory approval pathways, including preparation and management of all regulatory submissions. Communicate with regulatory authorities.
• Maintain and manage the QMS and report to management on the effectiveness of the QMS, including any need for improvement.
• Serve as the person responsible for regulatory compliance (PRRC) under MDR 2017/745, inclusive of the performing the duties expected of the PRRC under MDR 2017/745.

Required qualifications:

• Engineering degree or equivalent.
• At least ten years of quality and regulatory experience in the medical device industry.
• Thorough understanding of quality systems (MDR 2017/745, ISO 13485, 21 CFR 820) and risk management (ISO 14971).
• A proven track record of successful leadership in implementing a pragmatic quality assurance program.
• Able to interpret and understand complicated processes and their documentation needs.
• Able to think analytically and good problem solving skills.
• Fluent in English and French.
• Disciplined and well organized.

Preferred qualifications:

• Experience obtaining CE mark.
• Experience in ISO certification.
• Experience in implantable medical devices.
• Experience in a start-up environment