Associate Director, Safety Medical Writing – Medical Device Vigilance (Remote)
Job Summary:
Parexel is seeking a highly experienced Associate Director, Safety Medical Writing to lead Medical Device Vigilance and Post-Market Surveillance (PMS) activities. This pivotal remote role requires an expert in global medical device regulations, including EU MDR and FDA, with the leadership skills to manage safety reporting and surveillance operations. Collaborate cross-functionally to ensure regulatory compliance and drive risk management strategies across our medical device portfolio.
Key Responsibilities:
Develop and implement medical device vigilance and PMS strategies aligned with global regulatory standards.
Ensure strict compliance with EU MDR, FDA, and other market-specific medical device regulations.
Oversee management of Individual Case Safety Reports (ICSRs), Medical Device Reports (MDRs), and PMS activities.
Direct the preparation and review of Periodic Safety Update Reports (PSURs) and Clinical Evaluation Reports (CERs).
Lead regulatory interactions with notified bodies and authorities concerning medical device safety.
Manage and mentor a team of medical device safety professionals; implement robust training programs.
Collaborate with Clinical Affairs, Quality Assurance, and Regulatory Affairs on integrated safety strategies.
Supervise development of Risk Management Plans (RMPs) and benefit-risk assessments.
Utilize data analytics for signal detection and safety trend evaluation.
Contribute to long-term strategic safety planning for medical device operations.
Required Skills & Qualifications:
Advanced degree in Life Sciences, Pharmacy, Medicine, or Medical Devices.
Minimum 8 years of experience in PMS/medical device vigilance, including 5+ years in leadership.
Expertise in EU MDR, FDA regulatory frameworks for medical devices.
In-depth knowledge of vigilance processes, PMS reports, ICSRs, and CERs.
Strong leadership, team management, and cross-functional collaboration abilities.
Proficient in safety data evaluation, risk assessment, and regulatory reporting.
Excellent verbal and written communication skills.
Perks & Benefits:
Opportunity to lead global safety operations in a top-tier CRO.
Remote working flexibility.
Professional growth via leadership programs, mentoring, and cross-functional exposure.
Involvement in shaping future medical device safety standards globally.
Collaborative and inclusive work culture.
Company Description:
Parexel is a global leader in clinical research and regulatory consulting, offering end-to-end drug development and medical device solutions. Known for its scientific excellence, Parexel supports pharmaceutical and healthcare clients worldwide with innovative, patient-focused services.
Work Mode:
Remote (India)
Call to Action:
Take your leadership in Medical Device Vigilance to the next level with Parexel. Apply now to join a globally recognized team shaping the future of patient safety.
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