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Ra Specialist, Uk, Ireland and Northern Europe
3 months ago
Group:RAQA**
Division:EMEA**
Location:Newbury, UK or Amsterdan, NL**
Grade: 9**
Position Summary
Develops and applies foundation level knowledge and understanding of the RA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation.
The Regulatory Affairs Specialist UK, Ireland and Northern Europe is responsible for supporting in ensuring compliance with local Regulatory requirements through registration, release and hold of all Stryker products under the requirements of the EU MDR and the new regulations introduced following Brexit.
The Regulatory Affairs Specialist UK, Ireland and Northern Europe will be part of the EMEA Local RAQA organization.
The role will be based in Newbury (United Kingdom) or Amsterdam (the Netherlands) and will report to the UK, Ireland and Northern Europe Associate Manager, Regulatory Affairs.
Key Activities & Accountabilities
- Execute RA activities in line with defined procedures and processes.
- Collect, organise and maintain files on local, regional, and global RAQA intelligence.
- Gather data upon request in order to facilitate product control in relevant ERP systems
- Maintain product registration records and facilitate product release in relevant ERP systems to ensure timely market access.
- Escalate regulatory compliance gaps and potential patient safety issues to the RA lead.
- Obtain RA information and documents as requested from various sources and platforms to support wider Business
- Support in internal RA processes relating to custommade registration, OEM registration, renewals, new product release and change notification
- Identifiy opportunities for continuous improvement and supports those activities across RAQA.
- Perform based on established targets, KPIs and objectives for RAQA.
- Provide support to EMEA / Country RAQA teams as appropriate.
Education
BSc degree in relevant field.
Experience
0-2 years' experience.
Knowledge/Competencies
- Project management and time management skills, writing, coordination, and execution of basic RA items.
- With supervision, performs work that is varied and that may be somewhat difficult in character, conferring with superiors on unusual matters.
- Undertaking assignments that are broad in nature, requiring originality and ingenuity
- Ability to take limited unreviewed action or decisions
- Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organisation, Design Divisions and thirdparty distributors.
- Prepares for meetings with regulatory agencies, internal and external audits and other stakeholders, with support.
- Assists in the preparation of briefings and other information documents.
- Communicates information and advises on RA requirements to other departments and business units.
- Engages in communication with regulators and other key stakeholders on routine matters with mínimal supervision.
- Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organisation.
- 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.
- High attention to detail and process consciousness.
- Strong IT skills, including Microsoft Office.
- Fluent in English
About Stryker:
Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes.
