Job Description

QVC CERTIFICATION SERVICES PVT LTD

We are seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs Department as a Regulatory Affairs Specialist. The ideal candidate will have a background in Biotechnology, Microbiology, Nanotechnology, Omics, Bioinformatics, Genetics, or related domains, along with a strong understanding of regulatory requirements for medical devices and IVDs.

JOB TITLE

: Regulatory Affairs Executive

JOB CATEGORY

: Regulatory

Department/Group

: Regulatory Affairs

Division

:- Medical Device & IVD

Location

: Ambala

Travel required:

Occasional

Will train applicant

: Yes

Position type

: Full Time Employment (FTE)

External posting URL

: www.qvccert.com

APPLICATIONS ACCEPTED BY

: Fax or Email:

Subject line

: Regulatory Affairs Executive Application

JOB DESCRIPTION

Role and Responsibilities

Conduct document review and gap analysis according to regulatory requirements, including EU MDR 2017/745, IVDR 2017/746, and Indian MDR 2017.

Review standard-specific and process-specific documents for compliance.

Analyze and identify gaps in validation processes.

Prepare PowerPoint presentations for training sessions based on industry requirements.

The Profile will be upgraded based on the performance.

Qualifications and Education Requirements

Graduate or postgraduate degree in Biotechnology, Microbiology, Nanotechnology, Omics, Bioinformatics, Genetics, or related fields.

Proficiency in Microsoft PowerPoint, Word, and Excel.

Knowledge of sterilization methods, material compatibility, laboratory principles, quality principles, and QMS (Quality Management System).

Familiarity with regulatory standards such as ISO 13485, ISO 14971, ISO 20416, and ISO 9001.

Awareness of regulatory rules and regulations, including the Medical Device Rules and Regulations for both the EU and India.

Preferred Skills

Excellent attention to detail and organizational skills.

Strong analytical and problem-solving abilities.

Effective communication skills, both written and verbal.

Ability to work independently and as part of a team.

Flexibility to adapt to changing priorities and deadlines.

Job Type: Full-time

Pay: ?15,000.00 - ?25,000.00 per month

Experience:

total work: 1 year (Preferred)
Work Location: In person