When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Experienced leader to oversee Medical Device Vigilance and Safety services. This role will be responsible for developing and implementing pre- and post-market surveillance (PMS) strategies, ensuring compliance with global regulations, and managing safety reporting for our medical device portfolio.
Key Responsibilities:
- Develop and implement medical device vigilance strategies aligned with regulatory requirements
- Ensure compliance with global regulations for medical devices, including EU MDR, FDA, and other market requirements
- Overall management of individual case safety reports (ICSRs) and medical device reports (MDRs) / post-market surveillance activities
- Direct preparation and review of Periodic safety update reports (PSURs), Clinical evaluation reports (CERs) and other regulatory submissions
- Lead discussions with notified bodies and regulatory authorities on safety data for medical devices / drug-device combination products, as applicable
- Manage a unit of medical device safety professionals, including implementing training programs
- Collaborate with cross-functional teams (Clinical Affairs, Quality Assurance, Regulatory Affairs) on safety strategies and product development
- Oversee risk management plans and benefit-risk assessments for medical devices
- Leverage data analytics for signal detection and trend analysis in medical device safety
- Contribute to long-term strategic planning for device safety activities
Qualifications:
- Advanced degree in Life Sciences, Pharmacy, Medicine, Medical devices or related field
- Minimum 8 years of experience in PMS / medical device vigilance, with at least 5 years in a leadership role
- Extensive knowledge of global medical device regulations, particularly EU MDR and FDA requirements
- Strong understanding of medical device vigilance processes and best practices