QARA Professionals – Medical Devices, Pharma, NHP Salary Range: $60,000 – $130,000

Location: Canada / United States (On-Site, Hybrid, or Remote)

About The Opportunity We are seeking Quality Assurance & Regulatory Affairs (QARA) professionals across Medical Devices, Pharmaceuticals, and Natural Health Products (NHP). This is an open call to build talent pipelines for a number of our clients who are actively hiring in these sectors.

Whether your background is in Regulatory Affairs (RA), Quality Assurance (QA), or both, we encourage you to apply.

We are actively hiring for the following QARA career levels:

• QARA Associate – 0–2 years of experience
• QARA Lead – 3+ years of experience
• QARA Specialist – 5+ years of experience
• QARA Manager – 5+ years of experience, with leadership responsibility

Key Responsibilities

• Support or lead regulatory submissions (FDA, Health Canada, EU MDR/IVDR, and other global health authorities).
• Maintain compliance with ISO 13485, ISO 14971, CFR 21 Part 11/820, MDSAP, GMP, GLP, and other relevant standards.
• Oversee or contribute to quality systems, including SOPs, CAPA, risk management, audits, and post-market surveillance.
• Collaborate with cross-functional teams (R&D, Manufacturing, Clinical, Operations) to ensure regulatory and quality requirements are integrated throughout the product lifecycle.
• Stay current with evolving global regulations and provide guidance on compliance strategies.
• Support regulatory inspections and third-party audits.

Qualifications

• Bachelor’s degree or higher in Life Sciences, Engineering, or a related discipline.
• North American industry experience in Medical Devices, Pharmaceuticals, or Natural Health Products (required).
• ROW (Rest of World) regulatory experience preferred, including EU, APAC, LATAM, or global submissions.
• Strong understanding of Quality Management Systems and regulatory frameworks.
• RAC (Regulatory Affairs Certification) preferred; additional certifications (e.g., ASQ CQA, ISO Lead Auditor) are assets.
• Excellent communication, documentation, and problem-solving skills.
• Ability to work independently and collaboratively in fast-paced environments.

What Our Clients Offer

• Competitive compensation ($60K–$130K, dependent on experience and role).
• Opportunities across startups, scale-ups, and commercial-stage companies.
• Roles available in on-site, hybrid, and fully remote settings.
• Career growth across multiple levels of QARA.
• The chance to make a meaningful impact in patient health and product safety.

#TSSHP LI-TS1 Job Posting ID: #16815348