Associate Director, Safety Medical Writing

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