Regulatory Affairs

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare.

We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

This is what truly matters to us.

Join our team now as:
**Head of Quality Management & Regulatory Affairs**

at Fast Track Diagnostics, a Siemens Healthineers company, in Esch-sur-Alzette, Luxembourg.

**As Head of Quality Management & Regulatory Affairs**
- You will implement overarching quality mission and strategy, and ensures implementation of an open quality culture, for all assigned quality areas and advise executive management on quality topics.
- You will act as Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC)
- You will lead and coordinate high performing Regulatory Affairs and Quality Management (comprised of Quality Control, Quality System, Quality Engineer) teams and individuals
- You will collaborate with business accountable units (e.g., R&D, Procurement, Manufacturing etc.) to achieve quality business goals
- You will provide and review a business
- and employee-centered management system including documentation, regulations, methods, and IT tools
- You will execute audit programs, increasing transparency, effectiveness, and efficiency of QM audits to create a business impact.
- You will drive the development of digital solutions related to quality to continuously improve process effectiveness and efficiency along the customer journey.
- You will manage quality-specific external communication towards customers and to external authorities (e.g. field actions, marketing and promotional materials).
- You will drive continuous improvement with your team and lessons learned across the organizations.
- You will contribute to the identification of internal and external regulations in cooperation with global quality QM team and ensures that the processes are developed to meet these requirements.
- You oversee and ensure efficient processes for global registrations and post market compliance

**Qualification and experience**
- You have a Bachelor’s or advanced degree in areas of life sciences, engineering or a similar field
- You have at least 5 to 7 years’ professional experience in a regulated Medical Device/In Vitro Diagnostic industry with a minimum of 3 years’ experience in people leadership and management. Experience in Molecular Diagnostics would be a plus
- You have demonstrated experience in developing organizational capability and the ability to lead and motivate teams as well as individual contributors
- You have a proven track record of bringing together the quality and regulatory functions in an international setting to create an organization that supports the business;
- You have demonstrated successful experience in managing Notified Body audits (e.g., ISO 13485:2016, MDSAP)As well as internal and supplier audits
- You have profound knowledge of the relevant quality management system regulations (e.g., IVDD, IVDR), standards and quality-related processes for in-vitro diagnostics (e.g. ISO 13485:2016, MDSAP)
- You have strong familiarity with Design Controls, Design Transfer, Design and Process Validation requirements, Risk Management, and related QSR and international regulatory requirements for IVDs.
- Excellent written and spoken English language skills
- Excellent communication and organizational skills.
- Travel up to 10% to other facilities may be required to support business needs
- Position will be based in Esch-sur-Alzette, Luxembourg
- To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our job’s alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes._

**Organization**: Siemens Healthineers

**Company**: Siemens Healthcare NV S.A. branch Luxembourg

**Experience Level**: Mid-level Professional

**Full / Part time**: Full-time