Quality & Regulatory Senior Manager – IVD Manufacturer - Frankfurt, Germany – €negotiable depending on experience, bonus, pension, 30 days annual leave

The Company

This is an excellent opportunity to work in a market leading, global IVD Manufacturer who were recently awarded with the “Top Employer 2023” award for medium sized businesses.

• Hugely successful company boasting progressive growth for 20+ years
• Impressive product portfolio, with an innovative, exciting pipeline of new products
• Products are marketed globally
• Dog friendly offices, with free parking
• The company is supported by an award-winning HR Team – testament to the supportive culture they have.

The Role

The Quality & Regulatory Senior Manager will be focused on Quality Assurance (70%) and Regulatory Affairs (30%). You will be responsible for;

• Develop and manage Regulatory and Quality systems ensuring compliance to ISO 13485, ISO 9001
• Manage product registrations mainly within EU and EMEA regions
• Support requirements for change controls and CAPA process including (product and product performance) regulatory impact and reporting requirements to notified bodies and foreign regulatory agencies
• Regulatory Compliance for technical documentation and the EU declaration of conformity are created and kept up-to date
• Ensure all post market surveillance adheres to legislation

You

• This position favours QA responsibilities so an ample QA background is essential.
• Some Regulatory Affairs experience is also required – product registrations and post market surveillance.
• IVD experience is essential along with knowledge of the relevant legislation
• Knowledge of ISO 13485, ISO 9001 is essential.
• Leadership experience is desirable, but this role will not have direct reports to begin with.

What should you do next?

This Quality & Regulatory Affairs Senior Manager role is one not to be missed; it encompasses the opportunity to work with an award winning IVD Manufacturer. To discuss this role further or to find out about other Quality & Regulatory Affairs jobs I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we'll be more than happy to assist.