Senior Manager Quality and Regulatory Affaires

hace 5 meses

Poligono Industrial Alcobendas, España Stryker Corporation A tiempo completo

**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.

**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 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 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 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 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 a demonstrated technical knowledge of medical device regulatory and quality requirements.
- 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.

  • Regulatory Manager

    hace 5 meses

    Alcobendas, España Precision Medicine Group A tiempo completo

    Precision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland.Position Summary:The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings,...

  • Senior Regulatory Compliance Specialist

    hace 6 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly motivated and detail-oriented Senior Regulatory Compliance Specialist to join our team. This role will be responsible for ensuring that Parexel stays up-to-date with regulatory updates and implements relevant requirements.Key ResponsibilitiesLead and coordinate all regulatory compliance activities, including research...

  • Project Quality And Risk Manager

    hace 2 meses

    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.Due to a growing portfolio, we are currently looking for an experienced Project Quality and Risk Manager This role could be either office or home based in any of the following locations: Lithuania, Romania, Serbia, Poland, Hungary, Italy, Croatia, Spain.The offices for given locations are all...

  • Senior Quality Assurance Manager for Camera and Sensor Products

    hace 1 día

    Alcobendas, Madrid, España Grooo Ab A tiempo completo

    Job DescriptionGrooo Ab is seeking a Senior Quality Assurance Manager to lead our camera and sensor product team. The ideal candidate will have a strong background in quality assurance, with experience in managing cross-functional teams and ensuring compliance with industry standards.About the RoleThis senior-level position requires the development and...

  • Regulatory Intelligence Specialist

    hace 3 semanas

    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve. We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team. As a Regulatory Intelligence Specialist, you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements...

  • Regulatory Affairs Specialist

    hace 1 mes

    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Regulatory Manager Job DescriptionPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support to ensure the timely preparation and submission of high-quality regulatory documents to regulatory authorities and...

  • Regulatory Intelligence Expert

    hace 4 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Empowering Excellence in Regulatory IntelligenceWe are seeking a highly skilled and detail-oriented Regulatory Intelligence Specialist to contribute to our team at Parexel. As a key member of our Regulatory Intelligence team, you will be responsible for ensuring that our organization stays up-to-date with regulatory updates and implements relevant...

  • Regulatory Intelligence Specialist

    hace 3 semanas

    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve. We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team. As a Regulatory Intelligence Specialist, you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements...

  • Regulatory Intelligence Specialist

    hace 3 semanas

    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team. As a Regulatory Intelligence Specialist, you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements...

  • Project Quality and Risk Management Specialist

    hace 4 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job DescriptionWe are seeking an experienced Project Quality and Risk Manager to join our team at Parexel. As a key member of our global quality team, you will be responsible for ensuring the highest standards of quality and risk management across our projects.Key Responsibilities:Develop and implement quality management systems to ensure compliance with...

  • Senior Regulatory Affairs Specialist

    hace 3 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Unlock Your Expertise in Regulatory Affairs with ParexelParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. As a recognized professional in your field of expertise, you will...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Job Summary:Precision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a Regulatory Manager, you will be responsible for providing regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures.Key...

  • Regulatory Intelligence Specialist

    hace 2 meses

    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.   We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team. As a Regulatory Intelligence Specialist , you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and...

  • Senior Quality Assurance Manager

    hace 4 semanas

    Alcobendas, Madrid, España Grooo A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced leader to join our team as the VV Team Lead at Grooo. The ideal candidate is a seasoned professional with a strong background in Validation and Verification (VV) processes, particularly within the realm of cameras, sensors, or related products. You are someone who not only understands the...

  • Senior Regulatory Affairs Expert with CMC and Project Management Experience

    hace 5 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    Are you a seasoned regulatory affairs professional looking for a new challenge? We have an exciting opportunity for a Senior Regulatory Affairs Manager / Consultant to join our team at Parexel. As a key member of our global pharmaceutical services organization, you will work on diverse projects, manage client relationships, and contribute to regulatory...

  • Regulatory Intelligence Specialist Position

    hace 3 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to play a crucial role in maintaining our compliance standards. The successful candidate will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory...

  • Regulatory Affairs Manager: Global Pharmaceutical Expert

    hace 1 semana

    Alcobendas, Madrid, España Parexel A tiempo completo

    At Parexel, we're looking for a seasoned professional to take on the role of Senior Regulatory Affairs Manager/Consultant. This is a client-focused project with no people management responsibility, offering the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical...

  • Senior Manager, Compliance

    hace 5 meses

    Poligono Industrial Alcobendas, España Stryker Corporation A tiempo completo

    **Why join Stryker?**: Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific. **Know someone at Stryker?**: As Senior Manager, Compliance, you will...

  • Regulatory Affairs Consultant Senior Director

    hace 4 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Parexel is a leading Clinical Research Organization (CRO) seeking an experienced Principal Regulatory Affairs Consultant.The ideal candidate will have strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.This role involves serving as a Project Leader,...

  • Senior Regulatory Affairs Specialist

    hace 5 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    At Parexel, we're driven by a shared purpose: to help our clients achieve their goals and improve patient outcomes. As a Senior Regulatory Affairs Specialist - CMC Expert, you'll be part of a dynamic team that's passionate about delivering exceptional results.About the RoleWe're seeking an experienced professional with expertise in Chemistry, Manufacturing,...