Regulatory Affairs Specialist
To ensure the appropriate licensing, marketing and legal compliance of BC Medical and Industrial manufactured products
Key Result Areas
- Ensuring continued compliance to all relevant regulatory and quality requirements
- Timely identification and co-ordination of QA/RA regulatory changes to ensure no negative impact on the business.
- Successful completion of mandatory training
Compliance with Health & Safety, QA/RA and Environmental procedures
- Liaise with QA/RA management throughout the global organisation to ensure consistent global approach to regulation compliance.
- Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.
- Ensure current regulations and standards are available.
- Generate and maintain the DMR/DofC.
- Attend and support Design review activity and generate environmental checklist, labelling, IFU and ER checklist.
- Manage ECR/ECO process including notification to S-BCs of changes which are notifiable under regulations.
- Initial review of complaints to determine and record reportability.
- Ensure reportable events are reported within timescales as required by all market regulations. Notify senior management as appropriate.
- Determine whether FSCA is required and generate a Recall File as necessary. Manage all activities and ensure Recall file is regularly updated.
- Support and supply information as required relating to Product Registration in any market including site /establishment registrations including FDA 510(k), CE Marking etc.
Support Change management process (ECR/ECO) and report changes to S-BCs as appropriate.
Qualifications & Experience
University degree in a scientific / engineering subject. At least five to ten years experience in a regulatory, QA/RA or quality role for a medical device manufacturer. Ability to perform ISO 9001 / 13485 audits and good understanding of EU MDD/MDR, FDA QSR and JPAL requirements and other key international regulations covering medical and industrial devices.
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