At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Purpose of the Role
Responsible for managing regulatory strategy, submissions, and compliance activities for medical devices for key markets, United States, Canada, and European Union. The role supports new product development, market authorizations, and lifecycle management (LCM) for medical devices, including combination products (drug device), companion diagnostics, while ensuring compliance with applicable regulations and ISO standards.
Key Responsibilities
Develop, document, and maintain end‑to‑end regulatory strategies for medical devices across the key markets, ensuring alignment with product technology, intended use, risk classification, and business objectives.
Manage preparation, review, and submission of regulatory dossiers, including: 510(k), PMA, Medical Device License applications, CE marking submissions, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE) submissions ensuring accuracy, consistency, and regulatory compliance of all submissions.
Maintain the dossiers by filing annual reports and manage post‑approval submissions and Lead change impact assessments for Design modifications, Manufacturing and process changes, Supplier and raw material changes, labeling changes by accurately assessing and classifying the changes and prepare and manage change submissions and notifications to agencies.
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Provide regulatory input on Human factors and usability engineering and assess regulatory adequacy of design and development documentation, Device verification and validation etc.
Review and assess preclinical testing data (bench, biocompatibility, electrical safety, EMC, etc.), Clinical investigation data and performance evidence and ensure clinical and preclinical data meet regional regulatory expectations and are appropriately aligned with device claims and intended use.
Manage activities related to supplier qualification, CAPAs, complaint handling, product performance and audits
Act as a regulatory point of contact and prepare and coordinate responses to regulatory authority questions, deficiencies, and follow‑ups, with agencies
Develop and execute engagement strategies with agencies, including Pre‑Submission meetings, key regulatory questions, and incorporation of agency feedback into development and submission plans.
Act as the regulatory strategy lead on cross‑functional project teams, translating complex regulatory requirements into actionable development and execution plans.
Communicate clearly (written and oral) internally (e.g., company personnel) and externally (e.g., regulatory agencies, auditors, vendors)
Stay abreast of regulatory agency regulations, directives, guidelines and policies, etc. that could have an impact on product development to assess approval pathways and issues
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Qualifications & Experience
Bachelor’s degree in Life Sciences, Engineering, Biomedical Sciences, or related field
Advanced technical degree (PhD, MBA) preferred
Experience
More than 15 years of progressive medical device regulatory experience
Hands‑on experience with: FDA submissions (510(k), PMA, IDE)
EU MDR and CE marking
Health Canada device licensing
Skills & Competencies
Extensive global regulatory and quality device leadership as demonstrated by experience (> 15 years), milestones reached (e.g., new registrations), and health authority engagements (e.g., FDA, EMA, and others)
Extensive regulatory and quality experience, including but not limited to, 510k, PMA, CE, ISO standards, audit experience, complaint management, and/or others
Experience with combination product (drug/device) required
Strong staff and organizational development experience (e.g., building teams, and coaching and training both new and experienced staff); demonstrated strengths in delegation, resource allocation, and workload prioritization.
Broad US and international experience in and across disciplines (global/regional strategy, product labeling, clinical, nonclinical, CMC)
Direct experience and expertise in authoring and filing regulatory documentation across major regulated markets
Ability and interest in building and/or working a nimble resourcing environment
Travel Estimate
Job Requirements
Educational Qualification
Master’s degree preferred.
Experience
Tenure: 15+ years
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
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