Jr. officer/Officer/Executive - Regulatory Affairs (US, Europe, Canada)

🧾 Job Title: Regulatory Affairs Specialist – Medical Devices (2–5 Years Experience)

Location:

Reports to:

Job Summary:

medical device industry

Key Responsibilities:

US (FDA) Regulatory Support:

• Prepare and submit:

• 510(k) premarket notifications

• PMA supplements

  or

  De Novo requests

  (if applicable)
• Support

  establishment registration

  and

  device listing

• Ensure compliance with

  21 CFR Part 820 (QSR)

  and

  UDI

  requirements
• Collaborate with the Quality team during

  FDA inspections

EU Regulatory Support:

• Compile and maintain

  Technical Documentation

  in accordance with

  EU MDR 2017/745

• Prepare and manage:

• CE marking submissions

• SSCPs (Summary of Safety and Clinical Performance)

• Declaration of Conformity

• Coordinate with

  Notified Bodies

  and participate in audits
• Assist in

  Post-Market Surveillance (PMS)

  ,

  Vigilance reporting

  , and

  Periodic Safety Update Reports (PSUR)

Cross-Functional & Strategic Support:

• Act as a Regulatory Affairs representative in

  Product Development Teams (PDT)

• Review and approve labeling, IFUs, promotional material, and packaging for regulatory compliance
• Participate in

  Change Control

  and assess regulatory impact globally
• Monitor evolving regulations (e.g., MDCG guidance, FDA guidance) and communicate impact to internal stakeholders

Qualifications:

• Bachelor's degree in

  Pharmacy

  , or a related discipline
• 2–4 years of experience in

  Regulatory Affairs

  in the

  medical device industry

• Experience with

  Class I or II medical devices

  under

  FDA

  and

  EU MDR

• Solid understanding of:

• 21 CFR 807, 812, 814, 820

• EU MDR Annexes II & III

  , and

  ISO 13485:2016

Key Skills & Tools:

• Regulatory submissions (510(k), CE Marking, EU MDR documentation)
• Use of tools like

  eSTAR (FDA)

  ,

  EUDAMED

  , or

  Regulatory Information Management (RIM) systems

• Strong

  technical writing and documentation

  skills
• Experience working with

  Notified Bodies

  and/or

  FDA reviewers

• Excellent organizational, problem-solving, and communication skills
• Ability to work cross-functionally in a matrix environment

What We Offer:

• Exposure to global regulatory strategies and cross-border product registrations
• Opportunity to work on innovative Class I/II medical technologies
• Career growth path in Regulatory Affairs & Quality Management
• Collaborative, fast-paced work environment

Kindly share your resume at amits@firsttimeusgenerics.com and/or sujitkumarfirke@firsttimeusgenerics.com