Senior Regulatory Affairs Specialist
About The Position
Senior Regulatory Affairs Specialist In this role you The Senior Regulatory Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products. This may include ventilators, oxygenators, and other accessories. The role will provide day-to-day regulatory support for new product development and sustaining activities including but not limited to change order support, regulatory planning, and other activities as directed by management. Your role: The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents. Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work with global regulators/competent authorities throughout review and approval process. Support activities required to maintain regulatory compliance as new or revised versions of standards and guidance documents are published. Monitor global regulatory landscapes and support implementation of regulation changes and executes quality plans to minimize business impact. Provides Regulatory assessment of product changes for launch and sustaining activities.
Requirements
- Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
- 5+ years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent OR 2+ years' experience with Master's Degree
- Experience with Regulatory Requirements - 21 CFR 820, EU MDR, ISO 13485, Regulatory Standards, Regulatory Submission Documentation - 510k, Health Canada licenses, EU MDR Technical Documentations, Product Registrations - US, EU, Canada, Product Labeling - US, EU, Canada
- US work authorization is a precondition of employment.
- For this position, you must reside in or within commuting distance to Murrysville, PA or Cambridge, MA.
Nice To Haves
- Regulatory Requirements
- Quality Management Systems (QMS)
- Troubleshooting
- KPI Monitoring and Reporting
- Data Analysis & Interpretation
- Process Improvements
Responsibilities
- Develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW
- Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents.
- Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work with global regulators/competent authorities throughout review and approval process.
- Support activities required to maintain regulatory compliance as new or revised versions of standards and guidance documents are published.
- Monitor global regulatory landscapes and support implementation of regulation changes and executes quality plans to minimize business impact.
- Provides Regulatory assessment of product changes for launch and sustaining activities.
Benefits
- Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
