Location: Nuvali, Sta Rosa, Laguna
Employment Type: Full-time, Hybrid set-up
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.
Skills:
- Proficient in MS Office and other documentation management tools.
- Strong English communication skills (written and spoken).
- Ability to analyze and interpret complex regulations effectively.
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
Job Type: Full-time
Pay: Up to Php60,000.00 per month
Schedule:
- Afternoon shift
Supplemental Pay:
- 13th month salary
Work Location: Hybrid remote in Calamba City