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:

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