Website Parexel Ltd
Post Name: Associate Director, Safety Medical Writing
Job Description:
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
