Regulatory Affairs Executive

1 week ago

Ambala, India QVC CERTIFICATION SERVICES PRIVATE LIMITED Full time

**QVC CERTIFICATION SERVICES PVT LTD**

**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)

**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.

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

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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