Regulatory Affairs

Job Title: Regulatory Affairs (Medical Devices)

Job Description

The RA oversees market access and regulatory strategy holding authority for global submissions planning regulatory pathways managing lifecycle approvals and engaging with regulatory authorities with a focus on global regulatory strategy.

Management of product registrations.

Ownership of technical documentation.

Preparedness for market access.

Roles & Responsibility:

Regulatory Affairs Technical submissions

• Define develop and execute regulatory strategies to ensure fast Time to market all new/existing products.
• Develop and maintain Technical Files/Design Dossier to comply with European MDD and maintain CE mark approval.
• Develop and Maintain Technical Files/Design Dossier to comply with compliances and standards (CDSCO 510K)
• Overseeing and Planning Compilation review and submission of Documents as per Country Specific regulatory guideline in medical device manufacturing and coordinating with them for registration.
• Prepare and maintain technical file and medical device master files as necessary to obtain and sustain product approval from applicable regulatory authorities
• Accountable for the preparation and mantainence of technical documentation in accordance with EU MDR 2017 and other regulations such as USFDA MDSAP and CDSCO
• Preparation of Post Marketing Surveillance Report Post Market Clinical Follow Up (PMCF) Report Periodic Safety Update Report (PSUR) Clinical Evaluation Report (CER) Clinical Investigation Report Usability Engineering Report Risk Analysis Report.
• Facilitate the preparation and submission of documentation required for regulatory approval of manufacturing in India site.

Regulatory Strategy Ownership

• Define regulatory pathways for new markets and customers.
• Regulatory risk assessment during customer onboarding
• Support regulatory strategy for business expansion across organization

Lifecycle Management

• Renewal management of any audit (surveillance regulatory certifications External audits from notified bodies or any customer audits
• The readiness and attentiveness regarding certifications and audits
• Act as RA representative and support resource on product development for new products approval/registration
• Notified Bodies and Competent Authorities
• Observe global regulatory changes and execute required system updates
• Act as Primary regulatory interface with Notified Bodies and Competent Authorities with

Technical Documentation Responsibilities

• Design History File (DHF).
• Device Master Record (DMR) familiarity- recheck
• CDSCO
• TCF

2. Regulatory Affairs & Global Compliance

Manage registrations and lifecycle maintenance for:

• EU (CE Marking MDR 2017/745)
• ISO 13485: 2016
• US FDA
• UK MHRA
• Health Canada
• CDSCO (India)
• MDSAP
• 510K

3. Audit & Compliance Management

• Regulatory audit readiness support
• Regulatory inspection coordination Lead and manage external audits (ISO regulatory authorities customers)
• Ensure timely closure of audit non-conformities (NCs)
• Ensure full compliance with laws regulations SOPs and industry guidelines

• 4. Cross-Functional Leadership & Coordination

• Coordinate with Production QC R&D Supply Chain and Materials departments
• Ensure manufacturing and QC processes comply with ISO and GMP
• Oversee vendor qualification approval monitoring and re-evaluation
• Review and approve MIS reports and present quality/regulatory updates to leadership
• Lead mentor and develop RA teams

5. Strategy Business Growth & Governance

• Contribute to organizational strategy by aligning quality and regulatory goals
• Support new business leads and market expansion from a /RA perspective
• Assess regulatory and quality feasibility for new products and markets
• Identify system improvements risk mitigation opportunities and productivity gains
• Ensure organization-wide adherence to quality and regulatory governance frameworks
• Global market access planning.
• Regulatory feasibility assessment for customer proposals.
• Support during pre-sales or business development discussions

Required Certifications

Mandatory / Highly Preferred

• ISO 13485:2016 Certified Lead
• ISO 14971 Risk Management Training
• EU MDR 2017/745 & 746 Training
• CDSCO
• US FDA 510k
• Health Canada
• UK MHRA
• Global submission