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Urgent! Regulatory Affairs Consultant Job Opening In Lima Metropolitana – Now Hiring Confidential

Regulatory Affairs Consultant



Job description

We are seeking an experienced Medical Device Regulatory Consultant to support regulatory strategy, submissions, and compliance activities for Class II and/or Class III devices.

This role will collaborate closely with cross-functional teams, ensuring products meet FDA and international regulatory requirements from development through commercialization.

Responsibilities

  • Develop, review, and execute regulatory strategies for new and existing medical devices, including US FDA, EU MDR/IVDR, and other international markets.

  • Prepare, compile, and submit regulatory submissions (e.g., 510(k), PMA supplements, IDEs, Technical Documentation, Design Dossiers).

  • Advise on regulatory requirements for product development, manufacturing changes, labeling, marketing claims, and clinical activities.

  • Assess the regulatory impact of design changes, manufacturing modifications, and process improvements.

  • Monitor and interpret changes in global regulations and standards, providing guidance to internal teams.

  • Support and lead interactions with regulatory agencies, including FDA, Notified Bodies, and other authorities.

  • Ensure all documentation is accurate, complete, and compliant with applicable regulations.

  • Train and mentor internal teams on regulatory processes and best practices.

Qualifications

  • Bachelor’s degree in a scientific or engineering discipline (advanced degree preferred).

  • Minimum 7+ years of regulatory affairs experience in the medical device industry.

  • Proven track record with successful US and international submissions for Class II/III devices.

  • Strong working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and MDR/IVDR requirements.

  • Experience with combination products, software as a medical device (SaMD), or IVDs a plus.

  • Excellent organizational, communication, and problem-solving skills.

  • Ability to work independently and manage multiple priorities in a fast-paced environment.

Details

  • Seniority level: Mid-Senior level
  • Employment type: Contract
  • Job function: Regulatory Affairs
  • Industries: Medical Equipment Manufacturing

Location: San Diego, CA.

Salary: $145,000.00–$165,000.00 per year.

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Required Skill Profession

Consultoría/asesoramiento



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