At a Glance
- Tasks: Lead regulatory strategies for FDA approvals and international clearances in medical devices.
- Company: Join DEKA Research and Development, a leader in innovative medical technology.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic team environment focused on innovation and excellence.
- Why this job: Make a real impact on healthcare by ensuring compliance and speeding up product launches.
- Qualifications: Experience in regulatory affairs and strong leadership skills required.
The predicted salary is between 60000 - 80000 £ per year.
DEKA Research and Development is seeking a Regulatory Affairs Project Manager to develop and execute regulatory strategies for FDA approvals and international clearances.
The role involves leading submission efforts (510(k)s, PMAs, IDEs) and guiding R&D on compliance throughout the product lifecycle.
You will mentor staff, lead agency engagements, and drive process improvements to shorten time-to-market while ensuring robust regulatory compliance across devices and related products.
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We think you need these skills to ace Regulatory Strategy Lead, Medical Devices in Manchester
Regulatory Strategy Development
FDA Approval Processes
International Clearances
Submission Management (510(k)s, PMAs, IDEs)
Compliance Guidance
Mentoring Skills
Agency Engagement
