Regulatory Affairs Executive

2 weeks 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 MDR17 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 Understanding of Risk Management per ISO 1947
  • Knowledge on documentation on post market surveillance, PMCF, clinical evaluation and UDI.
  • Exposure to EU Medical Device Regulation (EU MDR) 2017/24
  • 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

( 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

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