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Regulatory Affairs Specialist- Gurgaon

3-6 years
Not Disclosed
10 Jan. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/B.E. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Regulatory Affairs Specialist

Location: Gurgaon, Haryana, India
Remote Type: Not specified
Time Type: Full-Time
Posted On: 27 Days Ago
Job Requisition ID: R17009


About Medtronic

Medtronic leads global healthcare technology, addressing humanity's toughest health challenges with innovative solutions. Our mission is to alleviate pain, restore health, and extend life, uniting a diverse global team of 90,000+ professionals who aim to engineer extraordinary outcomes.


A Day in the Life

As a Regulatory Affairs Specialist, you will oversee regulatory compliance systems and support regulatory affairs activities for India Medtronic. You’ll manage submissions, approvals, and renewals for medical devices across various business units, while interpreting federal and local regulations. Your role ensures regulatory compliance from product inception to post-market activities.

Key Responsibilities

  • Prepare and submit regulatory documents, license renewals, and annual registrations.
  • Recommend labeling, manufacturing, marketing, and clinical protocol changes for compliance.
  • Monitor and improve regulatory tracking/control systems.
  • Stay updated on regulatory procedures and changes.
  • Interact with regulatory agencies for approvals and clinical trial applications.
  • Provide guidance and technical support for regulatory requirements (e.g., CDSCO, FDA, CE).
  • Assist with internal audits and inspections.

Qualifications

Must-Have:

  • Education: B Pharm/M Pharm or Bachelor's/Master’s in Biomedical Engineering/Science with regulatory affairs training.
  • Experience: 3-6 years in the pharma/medical device/life science industry, with at least 2-3 years in regulatory affairs for medical devices.
  • Knowledge of Indian regulatory requirements (e.g., medical device registration, clinical trials).
  • Understanding of CDSCO, FDA, CE, and Quality Systems regulations related to design and manufacturing.

Nice-to-Have:

  • Strong verbal and written communication skills in English.
  • Effective communicator and team player with a customer-focused mindset.
  • Ability to establish credibility with regulatory agencies and government authorities.
  • Self-motivated with a positive "can-do" attitude.

Differentiating Factors

  • Autonomy: Works independently on moderately complex projects.
  • Impact: Contributes to project milestones and cross-functional assignments.
  • Complexity: Analyzes broader issues and adjusts systems to improve outcomes.
  • Communication: Engages with internal and external stakeholders to inform and gain input.
  • Leadership: May guide and assist entry-level professionals.

Benefits & Compensation

  • Competitive salary and flexible benefits package.
  • Short-term incentive eligibility under the Medtronic Incentive Plan (MIP).
  • Comprehensive resources to support employees at every career and life stage.

About Us

At Medtronic, we foster innovation and collaboration to solve real-world health challenges. With a commitment to diversity and excellence, we strive to improve lives through bold, compassionate solutions.

For more information about our mission, business, and values, click here.