Regulatory Affairs Consultant

BioTalent; Lima Metropolitana; Presencial; PEN 513.092 - 583.864; A tiempo parcial

Descripción de la vacante

A leading medical device consulting firm in Lima, Peru, is seeking a Mid-Senior level Medical Device Regulatory Consultant. The role involves developing and executing regulatory strategies, preparing submissions, and guiding compliance activities for Class II and III devices. Ideal candidates will have over 7 years of regulatory affairs experience and strong knowledge of FDA and international standards. The position offers a competitive salary between $145,000 and $165,000 per year.

Formación

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

Responsabilidades

• Develop and execute regulatory strategies for medical devices.
• Prepare and submit regulatory submissions like 510(k) and PMA supplements.
• Advise on regulatory requirements for development and manufacturing.

Conocimientos

Regulatory strategy development

Regulatory submissions

FDA regulations

ISO standards

Communication skills

Problem-solving

Educación

Bachelor’s degree in a scientific or engineering discipline

Descripción del empleo

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.