ProClinical has a brilliant opportunity for a Regulatory Affairs Specialist, based in Yorkshire. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors.
With little to no supervision the RA Specialist will provide assistance in preparation and submission of global regulatory documents.
- Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities
- Lead the submission of licenses and authorisations for the maintenance of existing products, international registrations, and dossiers.
- Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials.
- Define data and information needed for regulatory approvals.
- Develop labelling specifications and approve proposed labelling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- Provide Regulatory Affairs support during internal and external audits.
- Plan schedules for regulatory deliverables on a project and monitor the project through to completion.
- Assists in the development of best practices for Regulatory Affairs processes.
- Represent Regulatory Affairs on cross-functional project teams.
- Partner with other functions to define and obtain data to assist with regulatory submissions.
Skills and Requirements:
- BS with minimum 6 years of experience or equivalent
- Substantial experience of US, EU and International Regulations
- Practical experience with the preparation and submissions for Class III medical devices (EU and USA)
- Knowledge of Additive manufacturing technology and associated regulations (Software), advantageous
- Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances
- Excellent written, verbal communication and presentation skills
- Leadership, encouraging and supporting internal collaboration across levels, creating effective solutions.
- Ability to partner and influence key stakeholders on NPD and Lifecycle teams.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44203 0789 542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.