Posted 4 months ago
Regulatory Affairs Lead
@ Norgen Biotek Corp.
Thorold, Ontario
Overview
Norgen Biotek Corp. is hiring a Regulatory Affairs Lead in Thorold, ON, to lead regulatory submissions and approvals for its medical devices. The role covers Health Canada, FDA, ISO and CE marking work, plus quality and post-market compliance. Full-time on-site, Monday to Friday 8:30am to 5:00pm, paying $60,000 to $70,000 CAD per year.
Pay:
$60,000–$70,000 a year
Responsibilities:
- Lead regulatory submissions to Health Canada, FDA, ISO and CE marking
- Maintain approvals and certifications with regulatory bodies
- Support quality assurance and GMP compliance
- Conduct post-marketing surveillance on medical devices
- Coordinate internal and external quality audits
Requirements summary:
- University degree in a scientific field
- Regulatory Affairs Certification
- 3+ years in quality or regulatory affairs
- Knowledge of ISO 9001:2015 and 13485:2016
- Knowledge of Canadian, FDA and EU IVD requirements
- Experience obtaining regulatory approvals
Tools & skills
Benefits mentioned
Source and dates
Source type not verified · jsonld
- Employer posting date
- 2026-07-09
- First seen by our source
- 2026-10-26
- Source record updated
- 2026-10-26
These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.
Job details
| Seniority | Lead |
| Department | Physicians & advanced practice |
| Experience | 3+ years |
| Hours per week | 37.5 |
| Schedule | day |
| Work setting | Office |
| Position | Mostly sitting |
| Physical demands | physical low · computer high |
| Languages | English |
| Licences & certifications | Regulatory Affairs Certification |
| Education | Bachelor’s degree (required) |
| Fields of study | Life Sciences, Biochemistry |
| Perks mentioned | Retirement plan, Transit support |
Summary and details written by AI from the posting; the employer’s posting is the authority.
Norgen Biotek Corp.
| Field | Value |
|---|---|
| Open jobs on Jobsy | 2 |
Job Overview
- Location: 3430 Schmon Pkwy, Thorold ON
- Department: Regulatory
- Pay: $60,000–$70,000 CAD per year
- Job Type: Full-Time, On-Site
- Work Hours: Monday to Friday, 8:30am to 5:00pm
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 [email protected].
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.
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