Due to continued expansion of our operations, we are seeking applications from a suitably qualified and experienced Reg Affairs Specialist
Responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance.
Takes ownership for regulatory decisions impacting projects/ changes, and defends those decisions to other functions/ regulatory agencies based on sound regulatory knowledge
Provides strategic thinking to achieve desired regulatory objectives.
Provide technical review of information to support regulatory submissions/ product files to assure accuracy, clarity of presentation and compliance with applicable laws, regulations, or standards.
Ability to recognize and communicate risk.
Interfaces with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
Review and update of EU Technical Documentation.
Prepares FDA regulatory files such as PMAs, PMA Supplements and Amendments, 30 Day Notices, Annual Reports and 510ks.
Review and approve documentation related to various aspects of the design control process e.g. product release and product labelling
Participate in Regulatory agency audits.
Liaise and provide support to regulatory colleagues in the International regions.
Demonstrate and actively promote highest level of professional regulatory discipline.
Liaises with both middle and senior management on any regulatory issues relating to their area.
What we’re looking for:
- Bachelor’s degree, preferably in a scientific or engineering discipline
- Working knowledge of current and proposed EU regulations for medical devices
- Experience with FDA submission e.g. PMAs, PMA Supplements and Amendments, 30 Day Notices, Annual Reports and 510ks
- 3+ years of professional work experience
- Strong project management skills (organized, meets deadlines, determines critical path items, good time management). Ability to effectively manage multiple projects
- Strong oral and written communication skills
- Strong proficiency with Microsoft Excel, Word and PowerPoint applications
- Effective written and oral communication, technical writing and editing skills
- Working knowledge of product development process and design control