Regulatory Affairs ( Medical Devices )

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: ₹50,000.00 - ₹70,000.00 per month

Experience:

• total work: 1 year (Preferred)

Work Location: In person