Regulatory Affairs Manager (PMS)

TechTiera Corporation; Calamba; On-site; PHP 800,000 - 1,000,000; Full time

Job summary

A leading company in the medical device industry seeks an Associate Regulatory Affairs Specialist - Radiofrequency. This entry-level full-time position focuses on creating high-quality technical documentation and ensuring compliance with regulatory standards. Ideal candidates will have a Master's Degree and relevant experience in regulatory writing within the medical or dental fields.

Qualifications

• Preferred Master’s Degree in natural, medical, or technical sciences.
• Experience in writing regulatory documents beneficial.
• Understanding of regulatory standards like MDR, ISO 10993-1, and ISO 13485.

Responsibilities

• Creating and maintaining technical documentation for compliance.
• Leading risk analysis and product-related risk documentation.
• Conducting post-market surveillance activities.

Skills

Regulatory compliance

Technical documentation

Quality assurance

Risk assessment

Education

Master’s Degree in natural, medical, or technical sciences

Job description

Education & Experience:

• Master’s Degree is preferred/Higher degree in natural, medical, or technical sciences .
• Experience in writing regulatory documents or a related field beneficial, ideally within the medical device or dental industry .

Your Responsibilities:

Regulatory Compliance & Product Safety:

• Creating, writing, reviewing, and maintaining high-quality technical documentation (e.g. biological evaluation, clinical evaluation ) in compliance with MDR , and other relevant standards ( e.g. ISO 10993-1, ISO 13485)
• Leading the identification, analysis, evaluation, and documentation of product-related risks for medical devices in accordance with ISO 14971 , with a strong focus on quality and compliance
• Leading the continuous post-market surveillance (PMS) activities for medical devices class I, IIa and IIb
• Keep up to date with the dynamic regulatory landscape for medical devices.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management, Information Technology

Associate Regulatory Affairs Specialist - Radiofrequency