Assistant Manager

3 - 7 years

3 - 6 Lacs

Posted:1 day ago| Platform: Naukri logo

Apply

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Purpose:(what contribution is this position supposed to make in business?)

The QMS and EU MDR Compliance Executive is responsible for ensuring compliance with ISO 13485, EU MDR (Regulation EU 2017/745), and other applicable quality and regulatory requirements. This role will support the development, implementation, and maintenance of the Quality Management System (QMS), oversee documentation control, conduct internal audits, and support regulatory submissions and audits as required.

Key Deliverables/Responsibilities of this position

Quality Management System (QMS):

  • Maintain and improve the ISO 9001:2015 / ISO 13485:2016-compliant Quality Management System.
  • Ensure effective implementation of quality procedures and policies.
  • Manage document control, change control, CAPA, non-conformances, and risk management processes.
  • Coordinate internal audits, supplier audits, and management reviews.
  • Monitor key quality metrics and report quality performance.

EU MDR Compliance:

  • Ensure ongoing compliance with EU Medical Device Regulation (EU MDR 2017/745).
  • Support the preparation and maintenance of technical documentation in accordance with Annex II and III of EU MDR.
  • Work with cross-functional teams to ensure products meet General Safety and Performance Requirements (GSPRs).
  • Coordinate with Notified Bodies during audits and technical file reviews.
  • Support UDI, PMS (Post-Market Surveillance), and vigilance processes under EU MDR.

Regulatory Affairs:

  • Assist with regulatory submissions and CE marking activities.
  • Maintain up-to-date knowledge of applicable regulatory requirements and changes.
  • Liaise with regulatory consultants, Notified Bodies, and competent authorities as needed.

4-

5-

6-

7-

8-

Required Technical Skills:

Knowledge of ISO 13485 & Regulation (EU) 2017/745

Required Behavioural Attributes:

Good learner

Interactive with team

Good communication skills

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now
BL Lifesciences (BLLS) logo
BL Lifesciences (BLLS)

Medical Equipment Manufacturing

New Delhi Delhi

RecommendedJobs for You

Warangal, Hyderabad, Nizamabad