Senior Manager Regulatory Affairs

Job Description

Job Title: Sr. Manager RA

No of Vacancy: 1

Job Location: Andheri

Years of Experience:10 - 20 years

Working Days: Monday to Saturday

Job Summary:

We are seeking a dynamic and experienced Senior Manager – Global Regulatory Affairs to lead regulatory strategy, compliance, and market authorization activities across all regions (including India, USA, EU, MENA, LATAM, and APAC ). The ideal candidate will manage end-to-end regulatory submissions and ensure compliance with CDSCO , USFDA , EU MDR , MDSAP , and other country-specific requirements for our wide portfolio of dental devices and technologies . This role will also drive cross-functional alignment and strategic planning to ensure timely market access and post-market compliance for global operations.

Key Responsibilities:

Global Regulatory Strategy & Submissions

Develop and lead global regulatory strategies for new product approvals, product changes, and renewals across multiple markets.

Oversee preparation and submission of regulatory dossiers including:

510(k) submissions for USFDA

Technical Files under EU MDR

CDSCO applications via SUGAM/NSWS

Market-specific files for LATAM, MENA, ASEAN, and Africa

Manage the lifecycle of product registrations, including change notifications, renewals, and labeling updates.

Documentation & Compliance

Oversee compilation and maintenance of technical documentation, Design Dossiers, CERs, Risk Management Files, SSCP, UDI, and IFUs.

Ensure that documentation complies with ISO 13485, 21 CFR Part 820, Schedule V – MDR 2017, and global GSPR requirements.

Ensure global labeling, UDI, and registration tracking systems are up to date and compliant.

Regulatory Intelligence & Risk Management

Monitor and assess regulatory changes, standards, and emerging guidance across geographies and proactively address business impacts.

Provide strategic guidance to product development teams on regulatory pathways and compliance implications.

Lead regulatory due diligence in new market expansions and partnerships.

Cross-Functional Leadership & Stakeholder Engagement

Collaborate with R&D, Quality, Manufacturing, Legal, and Marketing teams to ensure product and process alignment with global regulatory expectations.

Serve as regulatory representative in design reviews, change control boards, and product launch meetings.

Act as the company's lead interface with regulatory bodies, notified bodies, consultants, and distributors for all global markets.

Team Management & Development

Build, mentor, and manage a high-performing global regulatory affairs team.

Establish global SOPs, templates, and best practices to ensure documentation quality and consistency.

Lead training and awareness programs across departments for regulatory requirements and changes.

Interdepartmental Coordination & Cross-functional Collaboration

Act as a regulatory liaison between internal departments including R&D, Quality Assurance, Manufacturing, Supply Chain, Legal, and Marketing to ensure seamless alignment of regulatory requirements during product development, changes, and market launches.

Participate in cross-functional meetings such as design reviews, risk assessments, CAPA boards, and change control committees to provide regulatory insights and approval.

Lead regulatory readiness for product launches by aligning internal teams on documentation, labeling, and certification requirements.

Vendor & Notified Body Communication

Maintain strong working relationships with Notified Bodies, regulatory authorities, consultants, and authorized representatives in global markets to ensure smooth product registration and certification processes.

Coordinate with external vendors, including regulatory consultants, testing labs, and CROs, for clinical evaluation, biocompatibility, performance testing, and regulatory submissions.

Act as the primary regulatory point of contact during audits or inspections conducted by external parties or authorities.

Required Qualifications:

Bachelor's/Master's in Pharmaceutical Sciences, Biomedical/Mechanical Engineering, Biotechnology, or Life Sciences

Advanced certifications in Global Regulatory Affairs, MDR/USFDA Compliance, or Clinical Evaluation preferred

Key Skills & Competencies:

Proven expertise in 510(k), EU MDR, CDSCO, and MDSAP regulations

Excellent understanding of global regulatory landscapes (LATAM, GCC, APAC, Africa)

Experience with e-submission portals: SUGAM, NSWS, EUDAMED, FDA ESG

Strong skills in technical documentation, clinical evaluation, and risk assessment

Ability to influence and communicate regulatory impact at the executive level

Strong leadership and team-building capabilities in a matrixed, global environment

Meticulous attention to regulatory detail, coupled with business strategy alignment

Preferred Industry Background:

Medical Devices (Class I/II/III)

Dental Products Manufacturing (e.g., clear aligners, restorations, implants)

Diagnostics or Life Sciences

Company website: