Work Flexibility: Hybrid
Sr Manager, RAQA (Hybrid)
Position Summary
Applies expert knowledge and understanding of the RA / QA / PMS frameworks,
legislative requirements, processes and procedures in the EMEA distribution
organisation. Direct and contribute to initiatives within the organization with groups
engaged in the development of good regulatory practice and policy.
Key Activities & Accountabilities
• Customised according to RA / QA / PMS pillars and country specific responsibilities.
• 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.
• Leads EMEA / Country RAQA teams as appropriate.
• Monitors team performance and takes action to keep the team on track by providing
appropriate coaching and feedback to others
• Team management and encouragement to ensure high performance in accordance
with our values
• Collaboratively works to set meaningful performance obectives and identify
milestones for goal achievement
• Act as RAQA Leader, reporting performance, risks and issues to local leadership teams
and other Stryker leadership teams where applicable.
• 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
• Leads 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
• Leads 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
• Leads integration of new acquisitions, ensuring RAQA systems integration within the
local office and across EMEA dependent on integration strategy.
• Represents Stryker in local industry association as RAQA subject matter expert in
advocacy activities of a more advanced technical and / or tactical or strategic nature
• Liaison with the local business in manufacturing and Design Divisions to ensure
adequate support for the local RAQA and commercial organizations
Education
BSc degree in relevant field. Advanced Degree preferred.
Master's Degree or equivalent desired.
RAC preferred.
Experience
10 years’ experience. 5+ years supervisory experience
Knowledge/Competencies
1. Demonstrated project management and time management skills, writing, coordination, and execution of more complex RA / QA / PMS items.
2. Demonstrated knowledge and application of regulatory requirements, including Medical Device Directive, EU Medical Device Regulations, Quality System and Post Market Surveillance requirements, as well as other international requirements pertaining to the medical device industry
3. Demonstrated technical knowledge of medical device regulatory and quality requirements
4. Demonstrated ability to effectively prioritize and manage multiple project workloads
5. Demonstrated ability to lead and develop employees and building effective teams
6. Demonstrated leadership skills
7. Experience with recruiting, hiring and developing talent
8. Demonstrated process improvement skills
9. Demonstrated ability to manage complex and multi-region projects within a matrix environment
10. Demonstrated ability to collaborate effectively with and lead cross-functional teams
11. Influence across the organization
12. Coordinate, support, and lead technical and scientific RA / QA / PMS activities.
13. Undertaking assignments that are broad in nature, requiring originality and ingenuity
14. Ability to take unreviewed action or decisions on business critical matters
15. Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organisation, Design Divisions and third-party distributors.
16. Leads meetings with regulatory agencies, internal and external audits and other stakeholders.
17. Prepares briefings and other information documents.
18. Communicates information and advises on RA / QA / PMS requirements to other departments and business units.
19. Engages in communication with regulators and other key stakeholders on both routine and business critical matters.
20. Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organisation.
21. Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
22. Connects and relates well with people who think and act differently than oneself.
23. Embraces scrutiny and accepts feedback as opportunity to learn and improve.
24. Preparation of RA / QA / PMS metrics for reporting purposes.
25. High attention to detail and process consciousness.
26. Strong IT skills, including Microsoft Office.
27. Fluent in English
Travel Percentage: 30%