Job
Summary:

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).

- 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.

- 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.

- Compliance Monitoring &
Market Surveillance:

- Monitor ongoing regulatory
changes and emerging requirements in non -EU and non -US markets.

- Ensure the company’s 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.

- 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.

- 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.

- 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.


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