QMS & Regulatory Expert

5 years

0 Lacs

Posted:2 days ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

About the Role:

QMS & Regulatory Affairs Specialist


Responsibility:

ISO 13485:2016

FDA 510(k)

Prepare and maintain regulatory documents including technical files, design dossiers, and labeling materials.

Collaborate with cross-functional teams (engineering, product, clinical) to ensure regulatory and quality compliance from design through post-market.

ISO 14971

Conduct internal audits, gap assessments, and assist in external audits or inspections.

Maintain QMS documentation including SOPs, work instructions, CAPAs, and training records.

Track and interpret changes in regulatory standards and implement updates accordingly.


Required Skills

  • Bachelor’s degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field.
  • 1–5 years of relevant experience in QMS and regulatory affairs within the 

    medical device or SaMD domain

    .
  • Good understanding of 

    ISO 13485

    IEC 62304

    ISO 14971

    , and related standards.
  • Exposure to regulatory pathways in 

    FDA, EU MDR, and/or CDSCO

    .
  • Strong technical writing skills
  • Detail-oriented with excellent communication 

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