Job Detail

Help us improve access to life-changing therapies that can transform human health

We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.

Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.

We are looking for a Post Market Surveillance and Complaints Leader (m/f/d) to work with our expert Quality Assurance team of 300 employees across the world. Do you have a passion for Post market and Complaints management, Quality and Regulatory compliance and ensuring customer satisfaction? Then we would love to hear from you.  

What you’ll do

• Developing and implementing post market survaillance and complaints processes and tools to manage the processes.


• Develop and monitor KPI’s reporting to QMR, PQSRB, CAPA boards


• Work with a variety of diverse persons within the company such as Project Managers, Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally.


• Maintain an excellent understanding of global medical device regulations in relation to Post Market Surveillance (PMS), Post Market Clinical Follow Up (PMCF), Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) and responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, MDR 2017/745, FDA QSP 21CFR Part 820 and others as required


• Input and adherence to the scheduling and management of PMS plans and reports, PMCF plans and reports and clinical evaluations. Maintains appropriate regulatory records to demonstrate compliance with applicable regulations


• Liaise and advise other Cytiva functional units (Engineering, Divisions, Quality etc) of the relevant requirements for PMS and PMCF and ensures the outputs from the individual functional units meet the applicable regulatory requirements. Review and analysis of data for same


• Review & analysis of adverse event/complaint information as required


• Support and review of Clinical Evaluation Plans and Clinical Evaluation Reports


• Lead a multidisciplinary team to ensure the site conduct comprehensive searches of published medical literature; write clear and effective generation of search protocols and reports, examination of clinical evidence and provide input to risk assessment and product labelling as well as clinical / regulatory strategies

Who you are

• Bachelor's degree in Science, Engineering, Biotechnology, Quality Management or Cell Therapy (preferred)


• requires a minimum of 5 years of related work experience.


• Has wide-ranging experience in post market surveillance and has deep complaint processing knowledge.


• Proven expertise in managing or leading compliant processing and improvement initiatives


• Knowledge of regulations pertaining to PMS, PMCF and CERs particularly in relation to the EU (MDD & MDR regulations) would be advantageous


• Computer experience required with working knowledge of Microsoft office programs


• Knowledge of medical device quality standards/practices or similar regulated industry


• Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form


• English business fluent, French is a plus

Who we are

Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.

Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!

Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.

Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.