Med Writing & Post-Market Surveillance Manager
Job ID: 8680
Location: Bengaluru, Karnataka, India
Work Mode: Hybrid (3 days onsite)
Employment Type: Full-Time
Category: Corporate Careers
Experience Required: 10+ years
Travel Requirement: Less than 10%
Job Overview
Zimmer Biomet is seeking an experienced Med Writing & Post-Market Surveillance (PMS) Manager to lead and oversee global post-market surveillance and medical writing activities in compliance with international medical device regulations. This leadership role is responsible for managing teams, driving clinical evidence generation, and ensuring regulatory readiness across the product lifecycle, with a strong focus on EU MDR compliance.
The role offers the opportunity to work cross-functionally with Regulatory Affairs, Quality, Engineering, and Product Management teams while shaping best practices in clinical evidence, surveillance strategy, and medical documentation.
About Zimmer Biomet
Zimmer Biomet is a global medical technology leader with nearly 100 years of innovation dedicated to enhancing patient mobility. Every eight seconds, a Zimmer Biomet product positively impacts a life somewhere in the world. The organization fosters a culture of inclusion, innovation, professional development, and performance excellence, empowering employees to make a meaningful global impact.
Key Responsibilities
Lead and manage post-market surveillance and medical writing activities, ensuring compliance with global regulatory requirements, including EU MDR 2017/745.
Oversee the preparation and review of PMS Plans, PMS Reports, PSURs, Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Summary of Safety and Clinical Performance (SSCP) documents.
Coordinate periodic evaluation of clinical evidence to demonstrate safety, performance, and state-of-the-art comparison of medical devices.
Partner with global PMS/MW teams and cross-functional stakeholders (Regulatory Affairs, Quality, Development Engineering, Product Management) to ensure robust clinical documentation.
Supervise, mentor, and develop a team of PMS and medical writing professionals, including workload planning, coaching, performance management, and skills development.
Monitor PMS performance metrics, proactively identify risks or delays, and implement mitigation strategies.
Support regulatory submissions, certifications, and responses to Notified Body or health authority queries.
Lead corrective and preventive action (CAPA) activities related to clinical documentation and surveillance findings.
Contribute to the development, maintenance, and continuous improvement of clinical PMS and medical writing policies and procedures.
Drive operational excellence, continuous improvement, and accountability within the team.
Required Qualifications & Experience
Education:
Bachelor’s degree in Health Sciences, Life Sciences, Biomedical Engineering, or a related discipline.
Master’s degree or PhD preferred.
Experience:
10+ years of overall experience in medical devices, with a strong focus on medical writing and post-market surveillance.
Minimum 5 years of hands-on medical writing experience, particularly in Clinical Evaluation Reports (CERs).
Proven people management experience in a regulated medical device environment.
Strong experience supporting EU MDR and MEDDEV 2.7.1 Rev. 4 requirements.
Technical & Professional Skills
Advanced medical, clinical, and regulatory writing expertise, including CER, SSCP, PSUR, CEP, and PMS documentation.
Solid understanding of post-market surveillance, risk management, and clinical evidence generation.
Experience with EU MDR/IVDR gap analysis, IVD regulatory affairs, and performance evaluation documentation.
Strong project management skills with the ability to manage multiple priorities and stakeholders.
Excellent written and verbal communication skills with internal teams, regulators, auditors, and senior leadership.
Ability to critically assess clinical data and translate complex information into compliant regulatory documentation.
Why Join Zimmer Biomet
Zimmer Biomet offers a collaborative, inclusive, and performance-driven environment where leaders are empowered to influence global regulatory strategy and patient outcomes. Employees benefit from strong development opportunities, competitive rewards, wellness initiatives, and the opportunity to contribute to life-enhancing medical technologies.
SEO & Search Keywords
Medical Writing Manager jobs in Bangalore, Post Market Surveillance Manager India, EU MDR Medical Device jobs, CER PSUR SSCP jobs India, Zimmer Biomet careers Bangalore, Medical Device Regulatory Writing jobs, Clinical Evidence Manager India.
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