What are the responsibilities and job description for the Regulatory Affairs Specialist – Medical Device position at TekOne IT Services Pvt. Ltd.?
Role: Regulatory Affairs Specialist – Medical Device
Location: Princeton, NJ 08540
Duration: 12 Months on W2 (On-Site)
Experience
Location: Princeton, NJ 08540
Duration: 12 Months on W2 (On-Site)
Experience
- Min. 3 years in Medical Device Regulatory Affairs
- Experience with IVD Devices in Regulatory Affairs
- Experience with US 510(k) submission in the last years
- Knowledge of EU MDR
- Experience with regulatory change assessments
- Proficiency in US and EU medical device submissions
- Support for internal and external inspections
- Ability to work cross-functionally in a matrixed environment
- Excellent technical writing skills
- Good communication skills
- BA Degree required
- Collaborate with business units to enhance regulatory processes
- Assist in strategy implementation for regulatory activities
- Develop product registration submissions and related documentation
- Update procedures to align with regulatory changes, including EU MDR
- Identify and implement opportunities for process improvement
- Technical writing examples preferred
