Regulatory Affairs Executive

2 days ago

Bengaluru Karnataka, India Tresbien HR Consultancy Full time

Hi

Opening with a client into medical Devices at Nayandahalli

Job Description Job Title: Sr. Executive - Regulatory Affairs

Reporting To: RA Manager.

Key responsibilities Duties:

- Experience in preparation of Device master file and other documents as per CDSCO MDR-17 requirements and submission of documents in CDSCO portal.
- Experience in preparation and submission of documents for Manufacturing licenses, Import licenses and for the certificates for all Class of devices (Class A, B, C & D).
- Experience with preparing design & development documentation including risk management to align with the regulatory strategy especially for class IIb implantable & class III devices.
- Experience for compilation of technical file/complete design dossier as per CE (EU MDR), ISO 13485 and USFDA guidelines.
- Need to do documentation as per FDA & CE-MDR regulations and ISO standards. Perform audit compliances, analysing gaps, shortcomings as per FDA/ISO regulations.
- Understanding of cGMP regulations per 21 CFR and ISO 13485. Understanding of Risk Management per ISO 19471.
- Knowledge on documentation on post market surveillance, PMCF, clinical evaluation and UDI.
- Exposure to EU Medical Device Regulation (EU MDR) 2017/245.
- Knowledge on device registration process in different countries.

Qualification:

- Master’s in Pharma with 2+ years of experience. OR Master’s in Science with 2+ years of experience, BE with 2+ years of experience
- Technical writing,
- English communication and teamwork.
- Detail oriented, ability to read various standards and guidelines & define implementation details.
- Result oriented to develop and deliver components in a short span of time

Regards

Smita Dewoolkar

9821574366
( Mobile & Whts app)

**Job Types**: Full-time, Permanent

**Salary**: Up to ₹500,000.00 per year

Schedule:

- Day shift
- Rotational shift

**Experience**:

- regulatory for class IIb implantable & class III device: 1 year (required)
- Regulatory reporting for medial device: 1 year (required)
- Compilation of Dossier fo EUMDR /USFDA: 1 year (required)

**Language**:

- English (required)

License/Certification:

- Master’s in Pharma OR Master’s in Science ,BE (required)

Ability to Commute:

- Bangalore, Karnataka (required)

Work Location: In person

**Speak with the employer**
+91
9821574366

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