Senior RAQA Manager - GSA

Excel with us as RAQA Manager for GSA!

This role will form a key part of our RAQA leadership team in EMEA and will lead a high functioning team Across the GSA region. If you have strong management experience in quality or regulatory affairs, we want to speak to you.

Who we want

• Strategic thinkers: Experts who understand complex RAQA and post‑market surveillance frameworks and translate regulatory intelligence into business strategies.
• Influential communicators: Leaders who represent RAQA priorities with stakeholders and regulators.
• Collaborative leaders: Partners who work cross‑functionally to support market access, compliance, and growth.
• People developers: Managers who build high‑performing, engaged teams across the GSA region.
• Process improvers: Professionals committed to continuous improvement across RA, QA, and PMS.

What you will do

• Lead RAQA operations across the GSA region, ensuring compliance with EU MDR, Swiss MedDO, quality system standards, and other applicable regulatory requirements.
• Drive regulatory excellence by overseeing market access processes, certifications, and regulatory intelligence management.
• Guide and develop RAQA teams by defining KPIs, coaching talent, and supporting recruiting and onboarding.
• Represent Stryker as the responsible person (CH‑Rep) for the Swiss Authorized Representative entity, engaging with regulators and industry associations.
• Advance continuous improvement through system updates, integration of acquisitions, and RAQA metric reporting.
• Develops and maintains awareness of RAQA mission and processes across the GSA 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.
• 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.
• Acts 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.
• Leads GSA RAQA teams to support regulatory processes for market access of products and applicable certifications.
• Leads 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 GSA offices.
• Defines targets, KPIs, performance objectives for RAQA within the GSA region.
• 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 GSA region.
• 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 associations 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.
• Serves as the responsible person for Stryker’s Swiss Authorised Representative (CH Rep) entity according to requirements of Switzerland’s MedDO. 

What You'll Need

• BSc degree in relevant field.  Advanced Degree preferred.
• Master's Degree or equivalent desired.
• RAC preferred.
• 10 years’ experience. 5+ years supervisory experience
• Demonstrated project management and time management skills, writing, coordination, and execution of more complex RA, QA, and PMS items.

• 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.
• Demonstrated 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.
• Demonstrated process improvement skills.
• Demonstrated ability to manage complex and multi-region projects within a matrix environment.
• Demonstrated ability to collaborate effectively with and lead cross-functional teams
• Influence across the organization.
• Coordinate, support, and lead technical and scientific RA, QA, and PMS activities.
• Undertake assignments that are broad in nature, requiring originality and ingenuity.
• Ability to take unreviewed action or decisions on business critical matters.
• 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.
• Prepares briefings and other information documents.
• Communicates information and advises on RA, QA, and PMS requirements to other departments and business units.
• Engages in communication with regulators and other key stakeholders on both routine and business critical matters.
• 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, and PMS metrics for reporting purposes.
• High attention to detail and process consciousness.
• Strong IT skills, including Microsoft Office.
• Fluent in English and German.