Regulatory Compliance Expert
23 hours ago
We are seeking a highly skilled Regulatory Affairs Specialist to support our Structural Heart business by developing innovative strategies for regulatory approval and providing strategic leadership to influence the global regulatory environment.
Key Responsibilities- Directs or performs coordination and preparation of document packages for regulatory submissions, ensuring timely and accurate delivery.
- Works closely with other Regulatory Affairs Specialists and international regulatory experts to provide regulatory support for changes to existing products, leveraging expertise to drive successful outcomes.
- Collaborates with engineers and technical experts to develop robust regulatory strategies, resolving questions from regulatory agencies and ensuring compliance with all relevant regulations.
- Leads or compiles all materials required in submissions, license renewal, and annual registrations, maintaining meticulous attention to detail and ensuring seamless execution.
- Supports change control activities to ensure global approval and implementation of product and process changes, fostering a culture of continuous improvement.
- Provides expert recommendations on labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance, driving business growth through strategic decision-making.
- Remains up-to-date on regulatory procedures and changes, developing internal procedures to ensure continuous compliance with all regulatory requirements, staying ahead of the curve.
- Qualified to Level 8 Science or Engineering honours bachelor's degree, demonstrating strong academic credentials.
- Minimum of 2 years of relevant experience in Regulatory Affairs, with a proven track record of success.
- Regulatory Affairs qualification is highly desirable, but not mandatory, indicating a high level of expertise in this field.
- Regulatory experience in Medical Devices and/or Pharmaceuticals is essential, showcasing a deep understanding of industry-specific regulations.
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