
Medical Device Compliance Professional
1 week ago
We are seeking a highly skilled Regulatory Affairs Specialist to fill a key role in our organization. The successful candidate will be responsible for post-market activities for medical devices, supporting departmental regulatory processes and procedures, and ensuring compliance with global regulations.
Key Responsibilities:- Support regulatory strategies for OUS medical devices and combination products
- Author and review regulatory documentation, including CIAs, Technical Documents, PMS Plans, PSURs, PMCF, and vigilance reports
- Complete global Post Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products
- Provide technical review of data and reports to ensure scientific rigor and accuracy
- Collaborate with cross-functional teams and external stakeholders to provide guidance and issue resolution
- Bachelor's Degree in science, math, engineering, or related discipline required; Master's Degree preferred
- 5+ years of medical device regulatory experience, with experience in EU MDD, EU MDR, and US FDA regulations
- Strong decision-making, communication, and technical writing skills
- Ability to work independently and manage multiple priorities
- Established scientific and quality expertise
- Experience in direct engagement with regulatory authorities
- Regulatory compliance competency in Quality Management Systems
Travel Requirements: Up to 13 business days per year
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