Regulatory Affairs Specialist – Medical Devices, IVD

This is a fully remote position, open to applicants in Philippines.

📋 Description

• Author Submissions & Technical Files: Develop and assemble technical documentation for EU MDR (Annex II/III), UKCA, and FDA 510(k) submissions.

• Maintain QMS Compliance: Assist in managing and supporting ISO 13485-compliant Quality Management Systems.

• Conduct Gap Analyses: Execute regulatory gap assessments in accordance with relevant regulations.

• Manage Risk & Clinical Data: Prepare risk documentation and draft/review Clinical and Performance Evaluation Reports.

• Drive Post-Market Activities: Aid in PMS activities and vigilance monitoring processes.

• Handle Agency Queries: Compose responses to regulatory inquiries.

• Ensure Audit Readiness: Keep regulatory files and submission trackers organized and up to date.

• Monitor Intelligence: Stay informed on evolving regulatory requirements.

⛳️ Requirements

• A minimum of 2 years of practical QA/RA experience specifically within the medical device or IVD industry.

• A background in biomedical engineering, life sciences, or a related technical field is highly regarded.

• Proficient understanding of ISO 13485, ISO 14971, and at least one significant regulatory market (EU MDR 2017/745, UKCA, or US FDA 510(k)/Part 820).

• Experience in independently managing complete submissions end-to-end or successfully addressing Notified Body/regulator queries is a substantial advantage.

• Familiarity with specialized standards like IEC 62304 (software), IVD requirements, or EUDAMED, along with knowledge of eQMS platforms (e.g., Qualio, Greenlight Guru, MasterControl).

• RAPS RAC certification is a notable plus.

• Exceptional written English skills tailored for documents intended for regulatory bodies.

• A self-starter who excels in a remote working environment.

🏝️ Benefits

• Remote work.

• Work from home option.