Develops and applies intermediate knowledge and understanding of the RA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. This role can be based in either Belgium or The Netherlands.
Key Activities & Accountabilities
Sits on the Benelux leadership teams and acts as a business partner for the local region
Executes RA activities in line with defined procedures and processes for the UK and BeNeNord region.
Collects, organises and maintains files on local, regional, and global RAQA intelligence.
Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
Identifies opportunities for continuous improvement and supports those activities across RAQA.
Performs based on established targets, KPIs and objectives for RAQA.
Provides support to EMEA/Country RAQA teams as appropriate.
Act as RAQA Leader, reporting performance, risks and issues to local leadership teams
Acts as a subject matter expert to the local business
Lead teams to support regulatory processes for market access of products
Lead the development and deployment of new systems and procedures locally
Plans, conducts, and supervises for Third Party, Competent Authority or Notified Body audits within the local organization
Supports continuous improvement activities across RA, QA and PMS activities within the local office
Defines targets, KPIs, performance objectives for RAQA within the local office
Supports recruiting, selection, on-boarding and development of talent within the local office to increase performance
Maintains a high level of team engagement and collaboration across the RAQA team in the local office
Supports integration of new acquisitions, ensuring RAQA systems integration within the local office
Represents Stryker in local industry association as RAQA subject matter expert in advocacy activities within the local Med Tech Organizations
Liaison with the local business in manufacturing and Design Divisions to ensure adequate support for the local RAQA and commercial organizations
3rd level Degree in Life Sciences. RAC certified preferred.
3-5 years experience. 1-3 years supervisory experience
Project management and time management skills, writing, coordination, and execution of more complex RA items.
Fluent in English and Dutch
Demonstrated knowledge and application of regulatory requirements, including Medical Device Directive, EU Medical Device Regulations, Quality System and Post Market Surveillance requirements
Demonstrate technical knowledge of medical device regulatory and quality requirements
Demonstrated ability to effectively prioritize and manage multiple project workloads
Demonstrated ability to lead and develop employees and building effective teams
Demonstrated leadership skills
Experience with recruiting, hiring and developing talent
Influence across the organization
Coordinate, support, and lead technical and scientific RA/QA/PMS activities.
Undertaking assignments that are broad in nature, requiring originality and ingenuity
Ability to take unreviewed action or decisions
Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organisation, Design Divisions and third-party distributors.
Leads meetings with regulatory agencies, internal and external audits and other stakeholders, with minimal support.
Prepares briefings and other information documents.
Communicates information and advises on RA/QA/PMS requirements to other departments and business units.
Engages in communication with regulators and other key stakeholders on routine and complex matters with minimal 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.
Preparation of RA/QA/PMS metrics for reporting purposes.
High attention to detail and process consciousness.