Home
/
Project Management
/
Senior Manager Quality and Regulatory Affaires (RAQA)
Senior Manager Quality and Regulatory Affaires (RAQA)-March 2024
Tres Cantos
Mar 21, 2025
ABOUT STRYKER
Stryker is a leading medical technology company driven to make healthcare better.
10,000+ employees
Healthcare, Technology
VIEW COMPANY PROFILE >>
About Senior Manager Quality and Regulatory Affaires (RAQA)

  What we are looking for:

  Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.

  Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

  Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures.

  Effective communicators. People who collect and interpret information accurately and can concisely communicate results and recommendations to stakeholders, senior management, and their teams.

  As our future Senior Manager, Regulatory Affaires, you will apply your expert knowledge and understanding of the RA / QA / PMS frameworks, legislative requirements, processes and procedures in the EMEA distribution organization at Stryker. You will set direction and contribute to initiatives within the organization with groups engaged in the development of good regulatory practice and policy.

  Whay you will do:

  You will be the Manager of our local RAQA team (7 people team), and as their leader you will be focus on talent development, performance orientation/review and coaching in accordance with our values. You will maintain a high level of team engagement and collaboration across the RAQA team in the local officeYou will identify the need for new regulatory procedures, SOPs, and participates in development and implementation of initiatives.Collaboratively, you will work to set meaningful performance objectives and identify milestones for goal achievement.You will act as RAQA Leader, reporting performance, risks and issues to local leadership teams and other Stryker leadership teams where applicable.You will be the main stakeholder for the local business as a subject matter expert.You will lead Third Party, Competent Authority or Notified Body audits within the local organization.You will support a culture of continuous improvement activities across RA, QA and PMS activities within the local office.You will be the leader of integration of new acquisitions, ensuring RAQA systems integration within the local office and across EMEA dependent on integration strategy. You will 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.You will be in permanent liaison with the local business in manufacturing and Design Divisions to ensure adequate support for the local RAQA and commercial organizations.

  Your profile

  You have a Bachelor or Master Degree in Regulatory Affaires, Business Administration or any related area to the role. You have at least 10 years of experience as Regulatory Affaires SpecialistYou have at least 5 years of experience in a People Management role. You have demonstrated project management and time management skillsYou have 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.You have a demonstrated technical knowledge of medical device regulatory and quality requirements.And overall, you are a leader by nature! You love to inspire your team, to set direction and to influence stakeholders as subject-matter expert.You are fluent in English (+ local language ideally).

  What do we offer in return?

  We grow talent; we give you the opportunity to develop your career based on your strengths. Stryker is a career destination for engaged passionate and talented people who are driven to seek the innovation, growth and opportunity that only we offer.

  Flat hierarchies and responsibility: through flat hierarchies, we strengthen the initiative and willingness of our employees to take over responsible tasks.Team spirit & engagement: we create engaged and inclusive teams that encourage colleagues to share their diverse perspectives and opinions.Recognition of your performance: at our company, outstanding individual and cross-functional team performance is rewarded. Ideas, projects, or other exceptional achievements can be submitted for various awards on a local and global level.Competitive salary: with us, you will receive a competitive remuneration package, benefits as well as a pension plan.

Comments
Welcome to zdrecruit comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
SIMILAR JOBS
Pflichtpraktikum / Abschlussarbeit - Forschung & Entwicklung / Lackentwicklung / Chemie- REF22033Q
Stellenbeschreibung Innerhalb unserer Abteilung Research & Development am Standort Weißbach suchen wir zum nächstmöglichen Zeitpunkt für eine Dauer von ca. 6 Monaten Studierende, die ein Pflichtp
Deputy Director of Child and Family Health
Job Description MassHealth is seeking qualified applicants for the position of Deputy Director of Child and Family Health. Reporting to the Director of Parent, Child, and Family Policy, the Deputy Di
CS Construction Project Manager
Job Description Job DescriptionAs a Construction Project Manager, you will be responsible for managing a portfolio of construction projects across the Costa Rica Site. Projects include small construc
Lead Capability Learning Solutions
About the Role We are seeking a strategic and experienced learning consultant to join our organization as Lead, Capability Learning Solutions. Through their deep knowledge and understanding of the dr
R&D Process, Systems and Regulations Trainer
Job Description As an R&D Process and Systems Trainer you will be responsible to local/regional R&D processes implementation, documentation and training as well as the multiplier functionas R
Director, Dynamics F&O Project Management
Introduction: Are you ready to steer the ship of successful project delivery? Join Avanade as a Director of ERP Project Management, where you'll be at the forefront of ensuring exceptional project ex
Commodity Manager
Job Description Supply chains have become more integral to corporate success as stakeholder expectations rise, product complexity increases, and risks to supply intensify in severity and frequency. I
CMC Facilitator
About the Role The CMC Facilitator supports and facilitates on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and
Value Added Services Pricing & Deal Operations (Sr. Manager / Sr. Consultant)
Company Description Visa is a world leader in digital payments, facilitating more than 215 billion payments transactions between consumers, merchants, financial institutions and government entities a
Direct Care Worker IV
Job Description This position is located at Hogan Regional Center 2 HC in Danvers, MA The Department of Developmental Services (DDS) is seeking to hire a Developmental Services Worker IV (DSW IV) who
Copyright 2023-2025 - www.zdrecruit.com All Rights Reserved