Regulatory Affairs Specialist
Job description
Randox require a Regulatory Affairs Specialist to work within our Quality Assurance/Regulatory Department based at the Randox Science Park, Antrim. Review websites on a regular basis to monitor updates to regulations and standards and to ensure any new relevant publications are purchased and reviewed. Review new/updated publications and summarise impact to the company..
Responsibilities
- Review websites on a regular basis to monitor updates to regulations and standards and to ensure any new relevant publications are purchased and reviewed.
- Review new/updated publications and summarise impact to the company.
- Present new publications to the Impact Assessment Team, take minutes of the Impact Assessment meeting and follow up on actions from the meeting.
- Ensure regulatory and design & development procedures comply with all regulations and harmonised standards.
- Inform all teams of updates to regulations and advise them what is required.
- Maintain the library of regulations and standards.
- Assist with the preparation and update of regulatory assessments of new devices.
- Work with departments to maintain the life-cycle of documents for Randox Products to assess the impact of changes to regulations and the updating of technical files following the implementation of changes.
- Perform detailed format reviews of the technical files to ensure consistency.
- Perform annual reviews of technical files and medical device files
- Review and approve product labelling (IFU).
- Provide regulatory support for customers, distributors and OEM partners.
- Work with the QA & Regulatory teams to ensure regulatory compliance and licenses are maintained.
Skills and Qualifications
Essential Skills
- Educated to degree level in a Science or Engineering related discipline or relevant experience
- Excellent communication skills (verbal and written) and ability to disseminate information in a concise manner
- Excellent leadership skills and a high level of self-motivation
- Ability to work methodically under pressure
- Proficient in use of Microsoft Word, Excel, PowerPoint etc
- Experience with interpretation of technical information and performance data
- Strong attention to detail
- Flexible approach and willingness to work outside hours if required
Desirable Skills
- Previous experience of working in a highly regulated industry
- Experience in preparing technical files
- Experience in a controlled manufacturing or analytical environment
- Experience in registering IVD products and CDx products in the US, Europe, China and/or Japan
- Knowledge of In Vitro diagnostics devices
Further Information
Work time: 08:40 - 17:20 to be confirmed.
- Vacancy ID
- 1586971
- Job ref.
- 23N/RATT
- Job Sector
- Business, Policy and Projects
- Area
- Co Antrim
- Location
- Science Park, Antrim
- Salary
- To be confirmed
- No. vacancies
- 1
- Contract Type
- Permanent
- Weekly hours
- 40
- Published date
- 27/01/2023
- Closing date
- 23/02/2023
- Worktime
- 08:40 - 17:20 to be confirmed