Science, Pharmaceutical & Food
Senior Reg Affairs Specialist
PE Global is currently recruiting for a Senior Reg Affairs Specialist on behalf of our client, either based in Galway or Shannon. This is an initial contract role.
The job requires the person to work within the current regulatory environment and frameworks for all relevant markets that wishes to market our products and to ensure in conjunction with the commercial requirements that all regulatory requirements for the individual markets are met and this involves a varied set of duties and responsibilities.
- In conjunction with the Sr Manager of RA and Design Assurance, define regulatory strategies for products within the product development process.
- As appropriate, manage CE mark submissions/Significant change notifications and Notified Body Interactions as directed by the Sr Manager of RA and Design Assurance.
- Assist when requested with the preparation of 510 (K) regulatory filings and subsequent FDA correspondences on supporting submissions.
- Assist in MDR activities as defined by the Sr Manager of RA and Design Assurance
- Complete and support regulatory submissions for global markets as defined by business requirements.
- Manage and complete regulatory assessments pertaining to Products and QMS changes, and complete subsequent registrations activities to regulatory agencies as an outcome of the regulatory assessment completed.
- Work in conjunction with the Sr Manager of RA and Design Assurance and cross-functional teams on the New Product Development initiatives.
- Work with commercial teams and distributors, to ensure country-specific requirements are understood and adhered to.
- Participate with Notified Body and Regulatory Agency audit preparation and follow-up.
- If required and deemed appropriate complete RA CSI activities supporting product release.
- Identify and initiate required action (s) to address any adverse events trends or regulatory compliance issues.
- Identify/work on continuous improvement initiatives within the regulatory department as deemed required
- Continuous review and monitoring of global regulations and the subsequent implementation of regulatory updates into the respective product files and procedures that were deemed necessary.
- Support all QMS related activities that were deemed required.
- A minimum of a degree in a Quality/Regulatory or related discipline, and at least 3-5 years practical and relevant experience in Regulatory Affairs, medical device preferable.
- Excellent verbal and written communication skills.
- Excellent attention to detail skills.
- Possess strong Technical Writing ability.
- Good understanding of ISO 13485 and FDA QSR quality standards., MDSAP, MDD, MDR 2017/745 & regional regulations.
***Interested candidates should send an updated CV to firstname.lastname@example.org or alternatively call 021 4297900***