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BL Lifesciences (BLLS)
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Assistant Manager

Assistant Manager

BL Lifesciences (BLLS)

3 - 7 years

3 - 6 Lacs

Greater Noida

Posted:3 months ago| Platform:

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Skills Required

ISO 13485 Audit Compliance EUMDR2017/745 Clinical Evaluation ISO Documentation QMS Implementation

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

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BL Lifesciences (BLLS)

Medical Equipment Manufacturing

New Delhi Delhi

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