Regulatory Affairs Lead

Benefits

• Dental care
• RRSP match
• Extended health care
• On-site parking

Responsibilities

• Lead the preparation, coordination, and compilation of documents for regulatory submission to Health Canada, The FDA, ISO and CE marking.
• Apply for and maintain approvals and certifications from various Regulatory bodies.
• Maintain knowledge on regulations, policies, and guidance documents for medical devices for Health Canada, The Food and Drug Administration, and the European Union for CE marking.
• Maintain knowledge of Norgen Biotek products and identify potential regulatory submission pathways and opportunities.
• Assist with liaising and negotiating with regulatory authorities.
• Keeping up to date with changes in regulatory legislation and guidelines.
• Offering guidance and advice about company policies, practices and systems.
• Support the quality assurance team to ensure company is following Good Manufacturing Practices and to monitor product compliance with applicable regulations and policies.
• Conduct post-marketing surveillance on Medical Devices.
• Coordinate in internal and external quality audits.
• Perform other duties as assigned.

Skills

• Proficient in computer applications (Microsoft Office, Word, Excel, PowerPoint, etc.)

Qualifications

• University degree in a scientific field (Life Sciences, Biochemistry, etc) is a requirement for this position.
• Regulatory Affairs Certification
• 3+ years of dynamic work experience in Quality/Regulatory Affairs.
• Knowledge and understanding of ISO ISO 9001/2015 and 13485:2016 is a must.
• Knowledge and understanding of Canadian Medical Device Regulations.
• Knowledge and understanding of the FDA 21 CFR 820 cGMP Requirements.
• Knowledge and understanding of the EU IVD Directive.
• Experience in applying for and obtaining approvals from regulatory agencies (Canadian, American, European).

Norgen Biotek is an equal opportunity employer. We celebrate diversity and are committed to creating a safe and inclusive work environment. For more information, or to request alternative accessibility formats, please contact Human Resources at hr@norgenbiotek.com.

Norgen Biotek understands the importance of transparency in the recruiting process. This position is intended to fill an existing vacancy. AI software may be used during the initial stages of the job advertisement and submission process.

Norgen Biotek thanks all applicants; however, only those selected for an interview will be contacted.