Regulatory Affairs Specialist

Roles & Responsibilities
• Assist in assembly, publishing, tracking, and archiving of global regulatory submissions
• Author, compile, and manage electronic regulatory submissions (eCTD and other formats)
• Support regulatory pathway research for new, modified, and existing products
• Provide regulatory strategy input to product development and cross-functional teams
• Review labeling, Instructions for Use (IFU), and package inserts for global compliance
• Evaluate promotional and advertising materials for regulatory adherence
• Assess product and process changes for regulatory impact
• Communicate with regulatory authorities under supervision
• Apply FDA, EU MDR, and other global regulatory requirements to business practices

Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related discipline

Experience
• Minimum 3+ years of experience in Regulatory Affairs, Quality, or Engineering
• At least 1+ year experience in medical devices or orthopaedics preferred

Skills
• Strong knowledge of FDA, EU MDR, and global medical device regulations
• Experience with regulatory submissions and electronic publishing
• Labeling and promotional material review expertise
• Regulatory risk assessment and strategy development
• Excellent writing, documentation, and communication skills
• Strong attention to detail and ability to multitask
• Proficiency in MS Office and regulatory documentation tools
• Regulatory Affairs Certification (RAC – US/EU)

About the Organization
Zimmer Biomet is a global leader in medical technology with nearly 100 years of innovation, specializing in orthopaedic solutions and advanced medical devices, offering strong global exposure and long-term career growth in regulatory affairs.