Assistant Manager, Regulatory Affairs Specialist

Responsibilities

• Develop and implement regulatory strategies for global markets including Canada, China, Japan, Brazil, Australia, and India
• Prepare, compile, and submit documentation for product registrations, renewals, and modifications
• Act as the primary point of contact for international regulatory authorities such as ANVISA, CFDA, PMDA, and Health Canada
• Coordinate product compliance with international standards including ISO 13485, GHTF, and IMDRF
• Monitor ongoing regulatory changes and emerging requirements in non-EU and non-US markets
• Collaborate with R&D, Quality Assurance, and Manufacturing teams to review technical documents and clinical data
• Manage regulatory submissions for product design updates and manufacturing changes
• Provide guidance on compliant labeling, advertising, and packaging materials for specific regions

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field
• 7-8 years of experience in medical device product registration, specifically focusing on global markets (excluding US FDA and CE)
• Deep knowledge of international regulatory frameworks (Health Canada, ANVISA, CFDA, PMDA, CDSCO, TGA)
• Strong familiarity with ISO 13485 and GHTF/IMDRF guidelines
• Excellent project management, communication, and organizational skills
• Experience working with regional consultants and third-party regulatory representatives

Preferred Qualifications

• Regulatory Affairs Certification (RAC) for international markets

Benefits

• Opportunity to manage registration for a diverse portfolio of over 300 products
• Exposure to global markets across more than 40 countries

About the Company

Founded in 2006, Meril is a global medical device company dedicated to the innovation, design, and development of state-of-the-art healthcare solutions. We manufacture a wide range of products, including vascular intervention devices, orthopaedic supplements, in-vitro diagnostics, and endo-surgery tools. Headquartered in India with a workforce of over 4,000, Meril conducts business in more than 100 countries to improve the quality of human life through advanced medical technology.