Regulatory Affairs Manager

The CellaVision Quality department consists of three teams, Regulatory Affairs, Quality Assurance, and Clinical Affairs. The main responsibility for Regulatory Affairs is product registrations to enable market access for our products. CellaVision owns product registrations in a number of major markets, but the majority of product registrations are managed in cooperation with distributors of CellaVision.



As RA Manager at CellaVision, you will be responsible for leading a small team with extensive expertise in Regulatory Affairs, where you will act as a cohesive and coaching force. An important part of your work will include leading and developing work methods, specialist competencies, and processes in the quality area. A challenge lies in seizing development opportunities and retaining already established strengths. You will report to Director Quality.



Key tasks as RA Manager

- Product registrations
- Staff, work environment, and budget responsibility for the RA function
- Leading, coordinating, and distributing work, delegating responsibilities
- Establishing and maintaining necessary procedures within your area of responsibility
- Being responsible for the company's contacts with authorities (FDA, NMPA, the Swedish Medical Products Agency, etc.)
- Working with registrations and providing documentation to distributors
- Create and maintain a regulatory strategy and plan for the company
- Vigilance reporting


- Since most of the company's written communication is in English, we see it as a necessity that you speak and write the language unrestrictedly and that in the role of a manager you have a good communicative ability.
- MSc or equivalent in the relevant field
- Many years of well-documented experience in Regulatory Affairs, preferably in a management position
- Experience in hands-on Regulatory Affairs work
- ISO13485, QSR
- Experience in regulatory work in the medical technology or pharmaceutical industry is a requirement




IVD experience is considered an advantage.

What can we offer you?

CellaVision has a world-leading position in digital cell morphology and we see our employees as our primary resource for our ongoing innovation and success. This is an excellent opportunity for you that wants to participate in the whole development process of medical devices where quality, development, and innovation are constantly in focus. Other great things with working at CellaVision are:

- We have a friendly and open company culture and a flat organization.
- We have flexible hours to promote a work-life balance.


- We have collective agreements, ITP-pension, parental leave supplement, reduction of work hours, etc.



Qualifications

- MSc or equivalent in the relevant field
- Many years of well-documented experience in Regulatory Affairs, preferably in a management position
- Experience of hands-on Regulatory Affairs work
- ISO13485, QSR
- Experience in regulatory work in the medical technology or pharmaceutical industry is a requirement




Who you are

As a leader, it is important that you are driven by the motivation and enthusiasm of your employees to perform at the same time as you are curious about new developments in the regulatory area. To be successful in the role of RA Manager, we believe that you are self-driven. You have a positive and constructive attitude to quality work and its role in daily operations. To be successful in the role of RA Manager we believe that you are business and result-oriented and have a strategic holistic approach and an ability to work hands-on. You are pragmatic and solution-oriented and are good at setting clear requirements and follow up on them. You have an analytical and structured mind and the ability and courage to make decisions and drive them through. Finally, we believe you have high integrity in your work.



Care to join?

Join CellaVision, put your skills to greater use, and help us contribute to lab efficiency and improved patient value worldwide.

Apply to this position by filling in the application form and attach your resume/motivational letter. Please prepare to have your documents, such as certificates, credentials, and recommendations, for a potential interview. We review applications continuously, so please send us yours as soon as possible but no later than May 28th, 2021.

This is a full-time position based at CellaVision HQ in Lund. To know more about the position, please contact recruiting manager Magnus Johnson, at magnus.johnsson@cellavision.se. We do not accept applications via email.

Questions about the recruitment process contact Caroline Herrlander HR Specialist, at cahe@cellavision.se

Note that you need a valid working permit in Sweden.



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