Senior Operations Executive - Medical Device Regulatory

Experience:

Location:

Company:

About us:

comprehensive regulatory affairs and compliance services for medical devices

Key Responsibilities:

• Prepare, review, and submit regulatory documentation for

  medical device registration and approvals

  in India and international markets (UAE, USA, Europe).
• Manage

  CE marking and EU MDR submissions

  , including technical file compilation and liaison with Notified Bodies.
• Handle USFDA 510(k), De Novo, and PMA submissions, including pre-submission meetings and correspondence.
• Support UAE MOHAP / SFDA / TGA / other GCC regulatory filings and country-specific dossiers.
• Stay updated with global regulatory changes and advise clients accordingly.
• Communicate with clients, regulatory authorities, and other stakeholders to ensure timely approvals.
• Review product labeling, IFUs, and promotional materials for compliance.

Required Qualifications & Experience:

• Bachelor’s / Master’s degree in Biomedical Engineering, Pharmacy, Life Sciences, or related discipline.
• 1-2 years of experience in Regulatory Affairs for medical devices (mandatory).
• Proven experience in global submissions – USFDA, EU MDR, CE marking, and UAE MOHAP or other GCC markets.
• Strong understanding of ISO 13485, ISO 14971 (Risk Management), and GMP requirements.
• Excellent written and verbal communication skills in English.
• Proactive, detail-oriented, and able to handle multiple projects simultaneously.

What We Offer:

• Opportunity to work on diverse international projects.
• Exposure to multi-country regulatory frameworks.
• Professional growth in a fast-expanding consultancy.
• Supportive and flexible work environment.