Associate Director, Safety Medical Writing
India, Remote求人ID R0000032268 Category Medical Writing
About this Role
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
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