Regulatory Affairs Specialist overseeing regulatory submissions in SEA for global medical device company. Ensuring compliance and managing stakeholder communications for product regulations.
About the role
- Senior Quality Lead driving non-conformance reduction and process validation in FDA regulated environments. Collaborating to oversee global quality and regulatory requirements for medical device manufacturing.
Responsibilities
- Act as Subject Matter Expert (SME) for non-conformance
- Drive non-conformance reduction and process validation maturity
- Implement and provide oversight of global Quality and Regulatory requirements
- Oversee the Quality Assurance activities in manufacturing processes
- Have an impact on introduction/validation of new/changed manufacturing processes
- Serve as best practice/quality resource within your discipline
Requirements
- 7+ years’ experience in quality engineering within FDA regulated medical device manufacturing environments
- strong knowledge of principles, theories, and concepts relevant to Quality Engineering (CQE body of knowledge)
- detailed knowledge of appropriate global medical device regulations, requirements and standards
- strong knowledge of Risk Management (ISO 14971, FMEA)
- Acceptance activities, Non-Conformance, Production and Process Controls, and Process Validation activities
- Minimum of a Bachelor’s Degree in Quality, Engineering or related field
- Lean Six Sigma Black Belt or Master Black Belt certified
Benefits
- generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
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