The Quality and Regulatory Affairs (QARA) Specialist will provide leadership in the quality and regulatory affairs function to understand regulatory requirements of medical devices, create relevant documentation and providing consultancy as an expert in regulatory affairs for IZiel clients
The RA specialist will work with clients in India and globally across USA and Europe to provide solutions for getting approvals for their products for launch in the Europe and USA
The candidate will require to go through extensive training in various country specific regulations as needed to keep themselves up-to-date with the latest and greatest updates as well as represent IZiel at various forums from time to time
The position will require support to make our clients highend products compliant to the new CE Medical Device Regulation (MDR)

POSITION RESPONSIBILITIES:

Having extensive knowledge of regulatory pathways for medical devices approvals in various countries with primary focus on US European regulatory pathways
Ability to research data and develop a regulatory strategy for approval of products for medical device manufacturers
Experience in creating and documenting a regulatory strategy successfully will be a plus
Should have knowledge of USFDA establishment registration device listing
Ability to write 510(k) and PMA applications with relevant information and input from the engineer in teams
Experience with preparing design development documentation to align with the regulatory strategy
Experience for compilation of technical file/design dossier as per USFDA and CE 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
File Annual reports and manage regulatory changes per the respective FDA and CE mark guidelines
Understanding of cGMP regulations per 21 CFR and ISO 13485
Understanding of Risk Management per ISO14971

DESIRED/PREFERRED QUALIFICATIONS:

Bachelors with 8+ years of experience OR Masters with 6+ years of experience
Willingness to travel, if required Strong Communication Skills (Written Oral) Team Player Technical Writing Experience in client co-ordination Experience with basic statistics and/or reliability methodologies
Detail oriented, ability to read various standards and guidelines define implementation details

More Jobs at Iziel Healthcare LLP

Quality and Regulatory Affairs (QARA) Specialist

pune

8.0 - 13.0 yrs

INR 25 - 30 Lacs

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