QMS Manager

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.

1- 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.

2- 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.

3- 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- Assist in compilation of technical files & related documentation:

Preclinical studies

Usability engineering as per EN 62366

Risk management reports as per 14971

Clinical evaluation reports – as per MEDDEV 2.7.1

5- Knowledge of EU Regulation (EU) 2017/745, to prepare & compile:

Post Market Clinical Follow up (PMCF)

It is the requirement of EU MDR, Annex XIV

PMCF shall be understood to be a continuous process that updates the clinical evaluation

Post Market Surveillance (PMS)

It is the requirement of EU MDR

Labelling requirements

It Is related to Labeling requirements of medical devices as per EU MDR. Means candidate must understand the related requirements & standard knowledge.

UDI requirement.

It Is also related to Labeling requirements of medical devices as per EU MDR. UDI is the new requirement which must be present in CE certified product labels.

Unique device Identification.

6- Preparation and amendments of quality system procedures

7- Assist in external audits & internal audits

8- Knowledge of Quality Control Operations & Problem Solving & Continuous Improvement

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

Good learner

Interactive with team

Good communication skills

Job Type: Permanent

Pay: ₹30,000.00 - ₹50,000.00 per month

Benefits:

• Health insurance
• Leave encashment
• Provident Fund