At Azenta Life Sciences, a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.

B Medical Systems, an Azenta Life Sciences company, was founded in 1979 when Electrolux partnered with the World Health Organization to create a solution for the safe storage and transport of vaccines around the world. Since that time, B Medical has become a global leader in vaccine cold chain. For over 35 years, we’ve been innovating and creating technologies that save lives across the globe.

In 2015, B Medical Systems was acquired by Navis, a private equity fund. Effective October 2022, a new chapter began and our company is a part of Azenta Inc., a leading worldwide provider of life sciences solutions.

Our Quality Assurance team is looking for a new talent, starting at the earliest possible time as Senior Manager Quality Assurance & Product Compliance (m/f/d) in Hosingen, Luxembourg.

How you’ll add value
We are looking for a Senior Manager Quality Assurance & Product Compliance (m/f/d), who ensure that products and services meet internal, legal and customer requirements by planning, directing and coordinating quality assurance programs and formulating quality control policies to improve the organization’s efficiency and profitability. Take regulatory responsibilities related to product compliance, risk management and post-market activities of medical devices. As PRRC (Person Responsible for Regulatory Compliance) exercise the duties as required by the European Medical Device Regulation (EU) 2017/745 – MDR.

What you’ll do

• Contribute to the creation and implementation of the strategy and development in terms of Quality Assurance activities.
• Establish the company’s Quality Management System (QMS) compliance to ISO standards, applicable regulations, and all associated tasks around Quality Management
• Support and collaborate with different internal departments in relation to Operational Quality (Production Quality, Quality Control, Supplier Quality), including participation in Quality Circle, support and overview of the CAPA activities.
• Act as company’s representative for all activities related to product certification and the registration of products in and outside the European Union
• Carry out and/or support all risk management activities and conduct risk assessments of processes and tasks
• Ensure the conformity in terms of Safety Officer for Medical Devices
• Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
• According to Article 15 of the European Regulation (EU) 2017/745 for medical devices, T
• The PRRC (Person responsible for regulatory compliance) responsibilities are according to the article 15 of the European Regulation (EU) 2017/745 for medical devices

What you’ll bring

• Successfully completed master’s degree in engineering
• Diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline
• 5 years of experience, ideally in regulatory affairs or in quality management systems relating to medical devices
• Work experience in an international and multicultural environment
• Excellent leadership and management skills
• Ability to manage cross-functional teams and to collaborate with business partners across multiple functions
• Planning and organization skills
• Strong communication skills – written, verbal and presentation
• Competent in problem solving, team building, planning and decision making
• Attention to detail
• Commercially aware
• Mircosoft suite
• Languages: English is mandatory any other language will be appreciated.

Our Offer

• Become part of a company that makes a positive contribution to launching groundbreaking scientific developments and therapies.
• Contribute to innovative cell therapies and be a part of revolutionary cancer therapies.
• Take advantage of the operational opportunities in a growing, modern, and innovative company within the health care/life science industry.
• Experience an intensive exchange of experiences and close cooperation in a worldwide network with our customers, friends and partners.
• We offer participation in national and international company events.
• After your initial training, you will receive regular training and further education opportunities that are tailored to your needs.
• A workplace that promotes your maximum.
• You will participate in capital-forming benefits, numerous corporate benefits.
• 33 days of vacation.
• Positive corporate culture and practiced teamwork across all locations.
• Individual development opportunities of your international competencies and language skills.

About us
Azenta Life Sciences is a global life sciences leader headquartered in Burlington, MA, with offices and operation sites around the world. We are the market leader in automated biospecimen management solutions and genomic services in areas such as drug development, clinical and novel cell therapies for the world's leading pharmaceutical, biotech, academic and healthcare institutions. Our laboratory analysis, sample management and storage, informatics software and consumables services offer unparalleled capabilities and have the largest installed base managing over one billion samples worldwide.

For more information: https://careers.azenta.com/
B Medical Systems S.à.r.l.
an Azenta Life Sciences company
17, Op der Hei
L-9809 Hosingen, Luxembourg
Christina Knappe (Senior Recruiter Central Europe)
christina.knappe@azenta.com