Join Parexel India as Associate Director – Lead Medical Device Vigilance Remotely

Parexel India -Associate Director: Safety Medical Writing

Parexel India is hiring for the position of Associate Director, Safety Medical Writing (Remote). This leadership opportunity focuses on managing and enhancing safety and regulatory compliance in the medical device domain. If you’re passionate about vigilance strategy, global regulatory frameworks like EU MDR and FDA, and leading impactful cross-functional teams, this could be your next big career move.

Parexel India

We are a company that values inclusivity, collaboration, and support to empower our employees to make a meaningful impact on people’s lives. Our culture promotes continuous learning and development opportunities.

Job Title: Associate Director, Safety Medical Writing

Location: India, Remote

Job ID: R0000032268

Category: 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 as Parexel India -Associate Director:

• 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
• Direct preparation and review of Periodic safety update reports (PSURs), Clinical evaluation reports (CERs), and other regulatory submissions
• Collaborate with cross-functional teams (Clinical Affairs, Quality Assurance, Regulatory Affairs) on safety strategies and product development
• 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

APPLY ONLINE HERE

Keywords: medical writing, Parexel India -Associate Director, medical device vigilance, safety services, regulatory compliance, global regulations, Job Postings, Associate Director, Medical Writing, Safety Medical Writing, Medical Device Vigilance, Post Market Surveillance, Regulatory Compliance, Remote Job India, Pharma Careers, Life Sciences Jobs