Associate Director – Safety Medical Writing (Medical Device Vigilance)
Location: Remote – India
Company: Parexel
Experience Required: Minimum 8 Years (including 5+ in leadership)
Job Type: Full-Time
Position Overview
Parexel is seeking an experienced and strategic Associate Director – Safety Medical Writing to lead Medical Device Vigilance and Safety Services. This high-impact leadership role will focus on developing and implementing post-market surveillance (PMS) strategies, ensuring regulatory compliance, and driving the safety reporting for a diverse medical device portfolio.
The ideal candidate will combine strong leadership and cross-functional collaboration skills with deep expertise in global medical device regulations (EU MDR, FDA, etc.).
Required Qualifications
Advanced degree in Life Sciences, Pharmacy, Medicine, Medical Devices, or a related field.
Preferred Experience & Skills
8+ years of experience in medical device vigilance/post-market surveillance.
5+ years in a leadership or managerial role within device safety.
Comprehensive understanding of global medical device regulations, especially:
EU MDR
FDA 21 CFR Part 803 and 820
Additional international market requirements.
In-depth knowledge of:
Medical device vigilance systems and workflows
Signal detection and data analytics
Safety case processing (ICSRs, MDRs)
Risk management planning and benefit-risk evaluation
Strong communication and interpersonal skills.
Experience leading and mentoring multidisciplinary teams.
Ability to engage with global regulatory authorities and notified bodies.
Key Responsibilities
Design and execute global medical device vigilance strategies ensuring compliance with evolving regulations.
Manage end-to-end post-market surveillance (PMS) processes, including safety case management and reporting.
Oversee the preparation, review, and submission of:
Periodic Safety Update Reports (PSURs)
Clinical Evaluation Reports (CERs)
Risk Management Plans (RMPs) and benefit-risk assessments.
Represent Parexel in interactions with regulatory agencies and notified bodies regarding device safety.
Lead and develop a team of medical device safety professionals, including onboarding and training.
Partner with cross-functional teams including Clinical Affairs, Regulatory Affairs, and Quality Assurance.
Apply data analytics and signal detection tools to identify safety trends and drive data-informed safety decisions.
Contribute to the long-term strategic direction of the global device safety function.
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