Job Description – Associate Regulatory Affairs Specialist
Company: Medtronic
Location: Nanakramguda, Hyderabad, India
Remote Type: Hybrid
Job Type: Full-time
Job Requisition ID: R42876
Posted: 6 Days Ago
About Medtronic
Medtronic is a global leader in healthcare technology, committed to alleviating pain, restoring health, and extending life. With a team of over 95,000 professionals worldwide, Medtronic drives innovation by tackling the most challenging health problems and engineering extraordinary solutions for patients.
Job Overview
As an Associate Regulatory Affairs Specialist, you will contribute to regulatory submissions, technical communications, and compliance support activities. This entry-level role provides the opportunity to grow in regulatory affairs while working closely with cross-functional partners and supporting global healthcare initiatives.
Key Responsibilities
Clinical Support
Collect, maintain, archive, and retrieve source documents to ensure compliance with SOPs.
Support leadership during audits by compiling necessary documentation.
Assist with submission-related activities, including CAP Agile uploads and Veeva review/upload.
Coordinate and support internal and external cross-functional meetings.
Track and report metrics related to medical writing and scientific communication deliverables.
Develop mechanisms for monitoring project progress and escalating issues to leadership when needed.
Regulatory Technical Communications
Create, review, and reproduce regulatory text for medical product labeling.
Ensure labeling, artwork, and proofs meet medical, legal, and regulatory requirements.
Monitor regulatory labeling changes in the US and international markets.
Review promotional and commercial materials for accuracy, data support, and compliance.
Recommend improvements to labeling processes, quality systems, tools, and policies.
Career Stream & Differentiating Factors
Specialist Career Stream: Individual contributor role focused on professional expertise.
Autonomy: Entry-level contributor working under close supervision.
Organizational Impact: Delivers work of limited scope, typically on smaller or less complex projects.
Innovation & Complexity: Identifies and solves straightforward problems; suggests minor process changes.
Communication & Influence: Interacts mainly with internal team members to gather and share information.
Leadership & Talent Management: Focuses on self-development; no direct leadership responsibilities.
Qualifications
Education:
Bachelor’s degree required (or international equivalent as per 8 C.F.R. § 214.2(h)(4)(iii)(A)).
Experience:
2–4 years of relevant regulatory or related experience.
Knowledge & Skills:
Broad theoretical understanding of regulatory affairs, typically acquired through advanced education.
Strong documentation and organizational skills.
Familiarity with submission systems (e.g., Veeva, CAP Agile) preferred.
Benefits & Compensation
Competitive salary package.
Flexible benefits designed to support employees across different life stages.
Recognition and rewards for contributions and performance.
Opportunities for career growth and development.
Physical Job Requirements
This description outlines the general nature of the role. It is not an exhaustive list of all duties, skills, or requirements. Additional responsibilities may be assigned as needed.
✨ This role is ideal for candidates looking to start or grow a career in Regulatory Affairs with a leading global healthcare company, gaining exposure to compliance, labeling, and submission activities in a supportive hybrid environment.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Tallinn |Hà Nội :
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Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
Springville | Belgium | Xzagreb | Slovakia | Bountiful | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Castlebar | Lenexa | Leinster | Nairobi | Riga | McFarland | Remote - Europe | Lousiana | Ireland | Green Way | Texas | Faridabad | Blue Bell | Remote, USA | Switzerland | Manipal | Medan | Tulsa | French | Victoria | Zaragoza | Remote - South America (Latin Americal) | Minnesota | Hungary | Remote - Africa | Melbourne | Remote - Middle East | Thailand | Remote | Hammond |Republic of Colombia :
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