Regulatory Specialist

The opportunity:

In this role, you will be responsible for regulatory affairs activities including customer complaints handling, assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. In addition, assist in maintenance of regulatory files, annual reports, registrations, and listings.

In this position you will be asked to:

Manage communication with FDA and other Regulatory Authorities, Regulatory Sponsors and Authorized Representatives regarding AE incidents and Recalls of company devices.

Complaint Handling, Adverse Event Reporting, & Vigilance/Trend Reporting process owner; Responsible for content of the processes and their correctness & completeness

Investigates & document customer complaints according to applicable regulatory requirements.

Serve as a liaison between Clinical Affairs, Production, and Complaint Handling to ensure Post Market Surveillance (PMS) processes are executed end-to-end

Review complaint trend analysis, clinical evaluation reports, risk management reports and FMEAs.

Assures compliance of local QMS procedure and updates as required.

Authors new or revised site procedures as assigned.

Assess the impact of new and updated standards

Review and determine the impact of change controls for existing devices, including labeling and management of registration, as applicable.

A successful candidate will have the following qualifications:

·Experience from a medical device company

Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QSR)

Experience with managing customer complaints, risk analysis

Excellent English language skills (verbal and writing)

Relevant degree (e.g., biomedical engineering or related science / technical discipline)

Bonus Points:

Experience with Class III implantable medical devices