Assistant Manager

The Product Registration Specialist for Global Markets is responsible for overseeing and managing the regulatory submission and product registration process for medical devices in non-EU and non-US regions. This includes countries such as Canada, China, Japan, Brazil, India, Australia, Russia, South Korea, and more. The role involves preparing and submitting the necessary documentation to regulatory agencies, ensuring compliance with local regulations, and facilitating timely market access

Key Responsibilities:

1. Regulatory Strategy & Compliance:

• Develop and implement regulatory strategies tailored to specific global markets (e.g., Health Canada, ANVISA in Brazil, TGA in Australia, SFDA in Saudi Arabia, PMDA in Japan, and CFDA in China).
• Stay updated with each region's specific medical device registration requirements, guidelines, and regulatory frameworks, including their unique classifications and submission types.
• Coordinate and guide product compliance with international standards, such as ISO 13485, GHTF (Global Harmonization Task Force), and IMDRF (International Medical Device Regulators Forum).

2. Submission & Documentation:

• Prepare, compile, and submit documentation for product registrations, renewals, and modifications for countries like Canada, China, Brazil, Japan, India, Australia, and others.
• Ensure accurate translation and localization of documents as required for regulatory submissions in different markets.
• Work with local consultants, distributors, or regulatory partners to facilitate registration in specific countries.

3. Liaison with Global Regulatory Authorities:

• Act as the primary point of contact with regulatory authorities in key regions such as ANVISA (Brazil), CFDA (China), PMDA (Japan), Health Canada, CDSCO (India), and TGA (Australia).
• Respond to regulatory authority questions, audits, and requests for additional information in a timely and effective manner.
• Maintain relationships with international regulatory bodies, consultants, and distributors to ensure smooth communication and regulatory pathways.

4. Compliance Monitoring & Market Surveillance:

• Monitor ongoing regulatory changes and emerging requirements in non-EU and non-US markets.
• Ensure the companys products comply with country-specific post-market surveillance, vigilance, and adverse event reporting requirements.
• Support regulatory audits and inspections by foreign regulatory agencies and notified bodies.

5. Cross-Functional Collaboration:

• Work closely with internal teams (e.g., R&D, Quality Assurance, Manufacturing, Legal) to collect and review the necessary technical documents, clinical trial data, product specifications, and test reports for regulatory submissions.
• Assist marketing and commercial teams by providing guidance on compliant labeling, advertising, and packaging material for each region.

6. Product Modifications & Renewals:

• Manage the regulatory submissions for product modifications and changes (e.g., design updates, manufacturing changes) across different global markets.
• Ensure timely renewal of product registrations and licenses to prevent market disruptions.

7. Regulatory Intelligence & Risk Management:

• Conduct regulatory intelligence and provide guidance on new regulatory trends, policies, and challenges in global markets.
• Assist in identifying regulatory risks and opportunities in new markets for product expansion

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.
• 3-5 years of experience in product registration for medical devices, with a focus on global markets (excluding US FDA and CE markets).
• Familiarity with key regulatory frameworks and authorities in international markets like Health Canada, ANVISA (Brazil), CFDA (China), PMDA (Japan), CDSCO (India), and others.
• Strong knowledge of ISO 13485, GHTF/IMDRF guidelines, and other international medical device standards.
• Excellent project management, communication, and organizational skills.
• Experience working with regional consultants and third-party representatives for regulatory submissions.
• Regulatory Affairs Certification (RAC) for international markets are a plus