Medical Device Regulatory Affairs Specialist

Fastdrive Consultancy

job title:

medical device regulatory affairs specialist

bhopal location

company: intense medical & dental system pvt ltd bhopal.

job brief:

we are looking for a skilled regulatory affairs specialist to manage and coordinate regulatory compliance for our medical devices. this role requires strong communication with channel partners, collaboration with documentation teams, and ensuring all products meet regulatory standards for both domestic and international markets.

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key responsibilities:

* ensure medical devices comply with all applicable national and international regulatory requirements and standards

* prepare and submit regulatory submissions, including 510(k), pma, and other global market registrations

* communicate with regulatory authorities (such as the fda, cdsco) to handle queries and support approval processes

* monitor and interpret changes in medical device regulations and assess their impact on the company

* provide regulatory guidance and training to cross-functional teams including r&d, qa/ra, and product development

* develop and implement regulatory strategies to support new product development and market expansion

* maintain organized, up-to-date documentation to demonstrate compliance and support audits

* collaborate with channel partners and internal documentation specialists to ensure consistent regulatory alignment

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requirements:

* bachelor’s degree in biomedical engineering, or electronic commination. or a related discipline

* 3–4 years of experience in medical device regulatory affairs

* strong knowledge of domestic and international medical device regulations (fda, eu mdr, iso , cdsco, etc.)

* excellent verbal and written communication skills

* high attention to detail, analytical thinking, and problem-solving ability

* experience working collaboratively across multiple teams

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preferred qualifications:

* regulatory affairs certification (rac)

* experience with class ii or iii medical devices

* familiarity with quality systems (., iso , fda qsr)

key responsibilities:

• quality assurance and control

• regulatory compliance

• process improvement

• supplier quality management

• key documentation and reporting

• Experience

  3 - 6 Years

• No. of Openings

  1

• Education

  B.E

• Role

  Regulatory Affairs Specialist

• Industry Type

  Hospitals / Medical / Healthcare Equipments

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office

• Face interview location

  Office No. G7, Bagroda Industrial Area, Bhopal Madhya Pradesh 462026