Med Writing & Post Market Surveillance Manager

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

Primary responsibilities for this position include supervision and support of post-market surveillance (PMS) and medical writing (MW) professionals in the performance of clinical post-market surveillance activities and the development of clinical documentation supporting a wide range of Zimmer Biomet portfolio products. This position will provide leadership and direction on the PMS and MW processes as well as on the coordination of clinical evidence and post-market surveillance activities required under European Medical Device Regulation (MDR) for registration and continued commercialization of medical devices.

These activities are performed in close collaboration with other functional areas including regulatory affairs, quality, development engineering and product management to ensure product registrations are supported by adequate clinical safety and performance data according to global regulations.

Work Location: Bangalore

Work Mode: Hybrid (3 Days in office)

How You'll Create Impact

• Manages the coordination and timely execution of post-market surveillance activities including the preparation of written documentation on periodic safety and performance review as well as periodic evaluation of clinical evidence to provide evidence on the safety and performance of Zimmer Biomet’s medical products, in light of current state-of-the-art and alternative treatments, in accordance with global regulatory requirements. This includes but is not limited to PMS Plans, PMS reports, PSURs, Clinical Evaluation Plans, Clinical Evaluation Reports and SSCPs.
• Partners with global PMS/MW teams and cross-functional stakeholders (Regulatory Affairs, Quality, Development Engineering, Product Management) to obtain needed inputs and ensure robust clinical documentation.
• Effectively oversees, supervises, directs, delegates, assists, and advises a team of post-market surveillance and medical writing professionals by planning, coordinating and reviewing work assignments, coaching and providing appropriate feedback, developing programs for training and growth of employees, creating group objectives and managing to achieve them. Provides performance input to senior management.
• Develops and maintains a positive, respectful and motivating team atmosphere.
• Influence others within a team to take action; interacts effectively with various functional groups; contributes significantly towards the establishment of best practices; serves as a resource and mentor.
• Independently identifies potential barriers to project completion and proactively implement effective strategies to avoid such barriers.
• Effectively communicates to all levels of the organization.
• Monitors the performance of post-market surveillance activities on an ongoing basis; assists in the resolution of identified issues and escalates to upper management as needed.
• Supports the development and management of policies and procedures in the field of Clinical Post Market Surveillance, Medical Writing and Clinical Evidence.
• Oversees and implements Corrective and Preventative Action tasks as assigned and supports regulatory remediation of clinical reports as required.
• Supports the PMS and Clinical Evidence tasks for regulatory submissions for product registration / certification as well as the review of NB (or other authorities) questions as a result of the submissions, ensuring timely and high quality responses.
• Proactively and positively manages changes in business priorities, identifies potential issues, plans mitigations and escalates appropriately to senior management.
• Delivers results, drives for continuous improvement. Sets high performance expectations and holds himself and his team accountable for the results expected. Acts with a sense of urgency.
  
  

What Makes You Stand Out

• Proven experience with global regulations for product surveillance, risk management and clinical evidence (e.g., EU Medical Device Regulation).
• Excellent written and verbal communication skills with direct reports, team members, regulators/auditors and senior levels of management.
• Minimum 5 years Medical Writing Experience relative to CERs.
• Previous people management experience.
• Ability to critically assess clinical information.
• Individual must be comfortable multitasking and managing many simultaneous requests in conjunction with other management stakeholders.
  
  

Your Background

Required Technical Skills

• Medical Writing is most critical, experience in Post Market Survelliance also helpful. Clinical, regulatory and technical writing skills involving Clinical Evaluation Report (CER), Summary of Safety and Performance Evaluation (SSCP), and Periodic Safety Update Report (PSUR) required for compliance with European Medical Device Directive 2.7.1 Revision 4 and EU MDR 2017/745.
• IVD regulatory Affairs, EU MDR/IVDR Gap Analysis, Performance Evaluation Report, Analytical & Clinical Report Reviews.
• Minimum five years’ successful experience in a medical device clinical strategic and/or management role.
• Strong project management and technical/medical writing skills.
• Proven people management experience.
  
  

Education And Experience Requirements

• Experience Range: 10+ Years.
• Bachelor’s degree (Master’s Degree / Ph.D. preferred) in health, life sciences, or engineering; a minimum of 6 years of experience in medical device quality, regulatory, clinical or engineering disciplines, or an equivalent combination of education and experience.
  
  

Travel Expectations

Less than 10%

EOE/M/F/Vet/Disability