Regulatory Affairs Manager

Position Summary

The Regulatory Affairs Manager is responsible for leading regulatory strategy, planning, documentation, and submissions for medical device products across global markets, including the EU (EU MDR), United States (FDA), India (CDSCO), and other applicable regions. This role ensures compliance with all regulatory requirements throughout the

product lifecycle and partners closely with cross-functional teams to support product development, registration, and market expansion.

Key Responsibilities

Regulatory Strategy & Planning

Develop and execute global regulatory strategies to support new product introductions, changes, and lifecycle management.

Interpret and apply regulatory requirements for EU MDR, FDA (21 CFR 820, 807, 814, 820.30), CDSCO, and other regional regulations.

Provide regulatory input in design reviews, risk assessments, clinical evaluations, and quality system activities.

Assess regulatory impact of product changes and create appropriate documentation for change submissions.

Regulatory Submissions & Documentation

Prepare, review, and manage regulatory submissions including:

EU MDR Technical Documentation (Annex II & III), CER, PSUR, PMS plans

FDA 510(k), De Novo, PMA, IDE, registration & listing CDSCO Medical Device Rules (MDR 2017) submissions, import licensing, device registration

Global submissions for additional markets (e.g., UKCA, Health Canada, TGA, GCC).

Maintain up-to-date regulatory files and ensure accuracy and completeness of all dossiers.

Coordinate with Notified Bodies, FDA, CDSCO, and other regulatory authorities during submission review and audits.

Compliance & Quality Support

Ensure compliance with ISO 13485, ISO 14971, IEC standards, and QMS requirements.

Support internal and external audits, including Notified Body audits and FDA inspections.

Monitor and interpret regulatory changes and communicate impacts to the organization.

Oversee labeling compliance, UDI requirements, IFU reviews, and promotional material approvals.

Cross-Functional Collaboration

Partner with R&D, Quality, Clinical, Manufacturing, and Marketing teams to ensure regulatory alignment.

Provide regulatory training and guidance to cross-functional teams.

Support supply chain and operations with product registrations, renewals, and export/import documentation.

Qualifications & Experience

Bachelors or Masters degree in Engineering, Life Science, Pharmacy, or related field. 5-10+ years of regulatory affairs experience in medical devices, preferably with global market exposure.

Strong working knowledge of EU MDR 2017/745, FDA medical device framework, and CDSCO MDR 2017.

Experience preparing and submitting Technical Files, 510(k), PMA, or equivalent dossiers.

Familiarity with ISO 13485, ISO 14971, GSPR, clinical evaluation, and risk management documentation.

Excellent communication, project management, and stakeholder coordination skills. RAC certification (EU/US) is an advantage