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 current 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.
You're the right fit if:
- Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
- 10+ 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,
📌 Senior Regulatory Affairs Specialist (Pune)
🏢 Philips
📍 Pune
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