Regulatory Affairs - Medical Device

Dear Candidate,

Currently we require Regulatory Manager for Medical device.

Location - Sohna, Haryana

Cab facility Available for Gurugram or Faridabad candidates.

Minimum Experience - 4+ years in Medical devices

Job profile:

Key responsibilities:

Spearheaded regulatory submission strategy for CE marking under EU MDR for Class IIa, IIb & III devices.

Authored and maintained FDA 510 (K) submission, including predicate device comparison and labeling review.

Developed and maintained Technical Files and Design Dossier for European markets.

Coordinated Clinical Evaluation Reports (CER) and Periodic Safety Update Reports (PSUR).

Acted as point-of-contact for notified bodies and regulatory authorities during audits and inspections.

Implemented and maintained ISO 13485:2016-Compliant QMS, prepared company for successful MDSAP audit.

Developed and maintained company-wide QMS in compliance with ISO 13485:2016 AND 21 CFR 820.

Conducted risk management activities as per ISO 14971:2019 and ISO/TR 24971:2020, including, AFAP, FMEA and Hazard Analysis.

Led PMS activity (Plan, Report and arrange the feedbacks, sales data and other regulatory requirement from Marketing team).

Prepare document related to the Post Market Surveillance, General Safety and Performance Requirement (GSPR) Risk Management process of Class III medical device as per MDR 2017.

Managed change control and regulatory impact assessment during product updates.

Develop regulatory strategies for new and modified radiological devices.

Provide guidance and feedback to regulatory affairs management.

If interested plz share your cv at hr.prathamsearch@gmail.com

Regards,

Khushi Asthana

HR Manager

Pratham search

Job Types: Full-time, Permanent

Pay: ₹700,000.00 - ₹1,200,000.00 per year

Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift
• Morning shift

Work Location: In person