Senior Regulatory Affairs Specialist
Company: Medtronic
Location: Gurgaon, Haryana, India
Department: Regulatory Affairs
Job Type: Full-Time
Work Mode: Flexible Work Arrangement
JOB OVERVIEW
The Senior Regulatory Affairs Specialist is responsible for leading regulatory submission activities, developing regulatory strategies, coordinating global registration projects, and ensuring compliance with international regulatory requirements. The role involves preparing regulatory documentation, supporting clinical trial applications, managing regulatory projects, interacting with regulatory authorities, mentoring team members, and driving continuous process improvements throughout the product lifecycle.
KEY RESPONSIBILITIES
Regulatory Submissions
Lead the preparation and coordination of regulatory submission packages.
Compile documentation for global product registrations.
Manage license renewals and annual regulatory registrations.
Support regulatory submissions across multiple business functions.
Ensure timely completion of regulatory deliverables.
Regulatory Strategy
Develop regulatory strategies for product approvals.
Recommend optimal regulatory pathways for clinical trial applications.
Monitor global regulatory changes and assess business impact.
Recommend labeling, manufacturing, marketing, and clinical protocol changes for compliance.
Support lifecycle management of regulated products.
Regulatory Compliance
Ensure compliance with FDA, EU, and global regulatory requirements.
Support internal audits and regulatory inspections.
Review regulatory documentation for completeness and accuracy.
Maintain regulatory compliance throughout the product lifecycle.
Ensure adherence to company policies, SOPs, and quality standards.
Project Management
Lead assigned regulatory projects from planning through execution.
Coordinate activities across cross-functional teams.
Monitor project milestones, timelines, and deliverables.
Improve regulatory tracking and control systems.
Support continuous process improvement initiatives.
Stakeholder & Health Authority Management
Interact with regulatory agencies on assigned regulatory matters.
Collaborate with Quality, Clinical, Manufacturing, R&D, and Commercial teams.
Communicate regulatory updates to internal stakeholders.
Build consensus across cross-functional project teams.
Support regulatory negotiations when required.
Leadership & Mentoring
Coach and mentor junior Regulatory Affairs professionals.
Review work performed by team members.
Share regulatory knowledge and best practices.
Support departmental training initiatives.
Drive operational excellence within the regulatory function.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Pharmacy
Life Sciences
Biomedical Engineering
Biotechnology
Medical Sciences
Healthcare-related discipline
Or a related field
Preferred
Master's Degree in a relevant discipline.
EXPERIENCE REQUIREMENTS
Required
Minimum 4+ years of Regulatory Affairs experience in the Medical Device, Pharmaceutical, or Healthcare Industry.
Preferred
Global regulatory submission experience.
Clinical trial application experience.
Product registration and lifecycle management.
Regulatory inspection and audit experience.
Project management experience.
Cross-functional leadership experience.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dún Laoghaire |Galway :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Greece |North Island :
Auckland |New Zealand :
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Croatia |Zagreb :
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