Location UK / Belfast
Job Type Not disclosed
Salary Not disclosed
Updated 4 days ago
Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards.
The RA Specialist will be responsible for the following activities:
Supporting interpretation of MDSAP and EU-MDR
Supporting the identification of actions required to ensure compliance with ISO 13485, MDSAP and MDR
Providing inputs to the project manager and Snr RA Specialist to support the creation of project plans for MDSAP and EU-MDR
Supporting and conducting updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with MDSAP and EU-MDR
Conducting updates to labelling, SOPs, work instructions and policy documents to ensure compliance with Stryker corporate SOPs
Supporting internal and external audits as required
Supporting regulatory submissions and registrations as required Managing the regulatory team on a day to day basis
Supporting creation of Quality Agreements as required
Level 6 qualification in Engineering, Science, or related discipline; or MS in Regulatory Science
Experience within a regulated environment preferred
Coordinate and support technical and scientific regulatory activities.
Under supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility.
Some evaluation, originality or ingenuity is required.
Clearly conveys information to peers, supervisors, and other stakeholders
Assists in the preparation for meetings with regulatory agencies and other stakeholders
Assists in the preparation of briefings and other information documents
Communicates information on regulatory requirements to other departments and business units
Composes routine communications with regulators and other key stakeholders
Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization
Seeks out diverse ideas, opinions, and insights, and applies them in the workplace
Connects and relates well with people who think and act differently than oneself
Embraces scrutiny and accepts feedback as opportunity to learn and improve
Basic Microsoft Office, MS Project, Adobe Acrobat
Time management skills, writing, coordination, and execution of basic regulatory items.