Jefe(a) de Calidad y RA (Distribuidor Equipos Medicos)

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.

• 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 office
• You 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.

• 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 Specialist
• You have at least 5 years of experience in a People Management role.
• You have demonstrated project management and time management skills
• You 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).

• 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.