Senior Regulatory Affairs Specialist
3 days ago
TalentSphere Staffing Solutions is a growing organization in the medical diagnostics sector seeking a highly skilled Senior Regulatory Affairs Specialist to lead regulatory projects and ensure compliance with global requirements.
Estimated Salary: $100,000 - $130,000 per annum based on industry standards and Vancouver's cost of living.
Key Responsibilities:
- Regulatory Leadership: Prepare and submit global regulatory filings (e.g., FDA, EU IVDR, Health Canada, PMDA, NMPA, HAS, and TGA) ensuring timely and accurate submissions.
- Compliance & Strategy: Develop and implement strategies to meet global standards, monitoring regulatory changes for impacts on products.
- Cross-Functional Collaboration: Partner with R&D, Quality, and Operations teams to ensure market readiness, mentoring junior staff and reviewing work for compliance.
- Process Improvement: Optimize regulatory workflows and documentation processes.
Requirements:
- Education: Bachelor's in Life Sciences, Biotechnology, or related field; advanced degree preferred.
- Experience: 8+ years in Regulatory Affairs, focusing on IVDs or medical devices.
- Skills: Strong understanding of global regulatory standards, excellent communication and project management skills.
About TalentSphere Staffing Solutions: We are a dedicated team of recruiters specializing in life sciences talent. Our expertise lies in finding the perfect fit for our clients' needs. If you're passionate about regulatory affairs and leading cross-functional teams, this could be your dream role
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