Job Title: Regulatory Affairs Specialist
Location: Nanakramguda, Hyderabad, India (Flexible Work Arrangement)
Job Type: Full-Time
Job ID: R50190
Posted: 16 Days Ago
Company Overview:
Medtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. With over 95,000 employees worldwide, we drive innovation to solve complex healthcare challenges and deliver meaningful outcomes for patients globally.
Position Overview:
We are seeking a skilled Regulatory Affairs Specialist with 4–8 years of experience to manage regulatory submissions, maintain compliance, and support clinical trial approvals. The role involves coordinating document packages, monitoring regulatory procedures, and interacting with agencies to ensure timely approvals. This position is ideal for professionals with a technical background (B.Tech) who are seeking to advance in regulatory affairs within the medical technology industry.
Key Responsibilities:
Prepare and coordinate regulatory submission packages across multiple company functions.
Compile materials required for submissions, license renewals, and annual registrations.
Recommend updates for labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance.
Monitor and improve tracking and control systems for regulatory activities.
Stay current on regulatory procedures, guidelines, and changes impacting the medical technology sector.
Interact with regulatory authorities on defined matters as required.
Recommend strategies to achieve the earliest possible approvals for clinical trial applications.
Provide guidance and support to entry-level regulatory team members.
Required Qualifications & Experience:
Bachelor of Technology (B.Tech) – Mandatory.
Minimum 4 to 7.9 years of experience in regulatory affairs, clinical submissions, or related roles.
Strong understanding of regulatory guidelines, documentation requirements, and compliance standards.
Proven ability to work independently on moderately complex projects.
Effective communication and collaboration skills with internal teams and external agencies.
Career Level & Impact:
Specialist-level individual contributor responsible for project delivery and compliance adherence.
Works independently with general supervision, contributing to project milestones and cross-functional initiatives.
May mentor junior professionals or provide guidance to support teams.
Benefits & Compensation:
Competitive salary with flexible benefits package.
Eligible for the Medtronic Incentive Plan (MIP).
Opportunities for professional development, mentorship, and career growth.
Supportive work environment emphasizing employee well-being and engagement.
Why Medtronic:
Join a global healthcare technology leader that empowers employees to innovate and deliver solutions that positively impact patient outcomes. Medtronic offers a dynamic work environment with opportunities for professional growth, learning, and global exposure.
Apply Today:
If you are an experienced regulatory affairs professional with a technical background and a passion for ensuring compliance in medical technology, apply now to join Medtronic as a Regulatory Affairs Specialist in Hyderabad.
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