Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes.
As a growing company, we are seeking a highly skilled Senior Manager Regulatory Affairs Specialist.
You will play a pivotal role in shaping and executing regulatory strategies for medical device software (SaMD) and IVD products.
This includes leading global regulatory submissions, collaborating with cross-functional teams, and ensuring compliance with evolving regulations.
Requirements :
- Bachelor’s degree or higher in Science, Engineering, Regulatory Affairs, or a related field.
- Regulatory Affairs Certification (RAC) is a plus.
- Minimum of 10 years of experience in regulatory affairs, with at least 5 years focused on software as a medical device (SaMD) or IVD products.
- Advanced knowledge of global regulations, including FDA, MDR, IVDR, MDSAP, and relevant ISO standards (ISO 13485, ISO 14971, IEC 62304).
- Regulatory Expertise : Extensive knowledge of regulatory requirements for IVDs and SaMD across the product lifecycle, including market approval, product changes, and post-market surveillance.
- Leadership & Influence : Ability to effectively communicate regulatory requirements to cross-functional teams, negotiate, and influence key stakeholders to ensure regulatory compliance.
- Quality Systems : Strong understanding of quality management systems (QMS), specifically as they relate to SaMD and IVD development and regulatory compliance.
Interested in learning more? Reach out directly [email protected]
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