Regulatory Affairs Manager

We are now looking for a Regulatory Affairs Manager

In this role you will support our global product registrations and compliance with the regulatory requirements, you will be responsible for CE marking (EU MDR) and Notified Body change notifications for our dental 2D and 3D imaging products. Regulatory Affairs Manager works together with the regional Regulatory Affairs teams and R&D developing most effective registration paths for new software and hardware products, and their accessories.

Regulatory Affairs Manager is responsible for developing and maintaining regulatory processes and tools, and attending regulatory audits as necessary.

Job Requirements:

• Engineering, Business or equivalent degree.

• Experience with EU MDR, US FDA, Health Canada, China NMPA registrations and regulatory requirements.

• Demonstrated knowledge of EU and US UDI regulations.

• Knowledge of applicable IEC and ISO standards and passion to learn also national and international x-ray standards.

• Drive and report Health Hazard Evaluations, Recalls and Field Actions.

• Fluent communication skills in English

Additionally, the following will be considered an advantage:

• Knowledge of MDSAP program.

• Experience with implementing requirements for Material Safety and Restrictions as well as corresponding reporting to authorities (Biocompatibility, WEEE, RoHS, SCIP, Cal Prop 65).

• Knowledge on Lean methodology and processes.

• Communication skills in Finnish.

As a person, you are self-motivated and able to work independently, yet an efficient team player, who strives for reaching the goals. You take initiative, learn quickly and enjoy facing challenges and solving problems. You have a sense of urgency and great attention to detail. You also enjoy working in an international company and multicultural environment.

We offer you inspiring challenges in a growing global health-technology business and an opportunity to work within a strong Lean culture. The position offers interesting and varying responsibilities, cross-functional teamwork and an attractive opportunity to excel your professional skills.

The position is based in Tuusula, Finland which is one of the R&D centers for dental imaging devices at Envista Corporation. The role allows working remotely, especially when working with the regional RA teams.

Please submit your application with a salary expectation and your CV by June 12, 2022. We are constantly going through new applications and the candidates with most compatible profiles will be invited to the next step of the recruitment process already during the application period, so if you want to join us act now!

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