Job Title: Regulatory Affairs Specialist
Location: Nanakramguda, Hyderabad, India
Job Type: Full-Time
Job ID: R45810
Posted: 30+ Days Ago
Company Overview:
Medtronic is a global healthcare technology leader committed to alleviating pain, restoring health, and extending life. With a workforce of over 95,000 professionals worldwide, Medtronic develops innovative medical technologies and therapies that improve patient outcomes across the globe.
Position Overview:
We are looking for a Regulatory Affairs Specialist with 4–8 years of experience to coordinate and manage regulatory submissions, maintain compliance, and facilitate clinical trial approvals. The role requires strong technical knowledge, attention to detail, and the ability to collaborate effectively across functions while ensuring timely regulatory deliverables.
Key Responsibilities:
Prepare, coordinate, and manage document packages for regulatory submissions, internal audits, and inspections.
Compile materials required for regulatory submissions, license renewals, and annual registrations.
Recommend changes for labeling, manufacturing, marketing, and clinical protocols to maintain regulatory compliance.
Monitor and enhance tracking and control systems for regulatory activities.
Stay current on regulatory procedures, guidelines, and updates.
Interact with regulatory authorities on defined matters as needed.
Advise on strategies to achieve the earliest possible approvals for clinical trial applications.
Provide guidance and mentorship to entry-level regulatory team members.
Required Qualifications & Experience:
Bachelor of Technology (B.Tech) – Mandatory.
Minimum 4–7.9 years of experience in regulatory affairs, clinical submissions, or related roles.
Strong understanding of regulatory compliance requirements for medical devices or clinical trials.
Proven ability to work independently on moderately complex projects.
Excellent organizational, analytical, and communication skills.
Career Level & Impact:
Specialist-level individual contributor responsible for project execution and regulatory compliance.
Works independently with general supervision on moderately complex projects.
May mentor junior staff and provide guidance within the regulatory team.
Benefits & Compensation:
Competitive salary with a flexible benefits package.
Eligible for the Medtronic Incentive Plan (MIP).
Opportunities for professional development, mentorship, and career advancement.
Supportive work environment focused on employee well-being and growth.
Why Medtronic:
Medtronic empowers employees to innovate, solve complex healthcare challenges, and positively impact patient outcomes. Join a global team that values professional growth, diversity, and inclusion while working with cutting-edge medical technologies.
Apply Today:
If you are an experienced regulatory affairs professional with technical expertise and a strong understanding of compliance requirements, apply now to join Medtronic as a Regulatory Affairs Specialist in Hyderabad.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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