Regulatory Affairs Specialist (Medical Devices) – Zimmer Biomet

Zimmer Biomet, a global leader in medical technology with nearly 100 years of innovation, is hiring a Regulatory Affairs Specialist in Bangalore, Karnataka. This role offers a unique opportunity to work on global regulatory submissions, labeling compliance, and regulatory strategy development for cutting-edge medical devices, particularly within the orthopaedic sector.

If you have experience in medical device regulatory affairs, FDA/EU regulations, and electronic submissions, this position provides an excellent platform to grow your regulatory career in a multinational environment.

🔍 Key Job Details

• Position: Regulatory Affairs Specialist
• Location: Bangalore, Karnataka, India
• Work Mode: Hybrid (3 days office)
• Employment Type: Full-Time
• Category: Quality & Regulatory
• Experience Required: 3+ Years
• Industry: Medical Devices / Orthopaedics

🧩 Roles & Responsibilities

• Assist in assembly, publishing, tracking, and archiving of regulatory submissions
• Author and manage electronic regulatory submissions (eCTD/other formats)
• Support regulatory pathway research for new and modified products
• Provide regulatory strategy input to product development teams
• Review labeling, IFUs, and package inserts for global compliance
• Evaluate promotional and advertising materials for regulatory adherence
• Assess product changes for regulatory impact
• Communicate with regulatory authorities under supervision
• Apply FDA, EU MDR, and other global regulations to business practices

🎓 Qualifications & Experience

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field
• 3+ years experience in Regulatory Affairs, Quality, or Engineering
• 1+ year experience in orthopaedic or medical device industry preferred
• Knowledge of FDA, EU, and global regulatory requirements
• Regulatory Affairs Certification (RAC – US/EU) preferred
• Strong writing, communication, and documentation skills

💼 Skills Required

• Regulatory submissions & documentation
• Risk assessment and regulatory strategy
• Labeling and promotional review
• Cross-functional collaboration
• Attention to detail and multitasking
• MS Office proficiency

🎁 Benefits at Zimmer Biomet

• Competitive salary and performance incentives
• Hybrid work model
• Career development and training programs
• Employee Resource Groups (ERGs)
• Wellness and recognition programs
• Inclusive and diverse workplace culture

📩 How to Apply

Application Link