Envista Holdings Corporation Senior Regulatory Affairs Manager in Uusimaa, Finland
KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community. KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential. KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.
KaVo Kerr is one of the world’s largest dental companies and among the largest health technology companies in Finland. Our dental imaging devices represent highest technology and knowledge within the industry and are among the market leader brands. Our way of working is driven by Lean methods and processes, and we are committed to continuous improvement.
We are now looking for a
Senior Regulatory Affairs Manager
to support our global product registrations and compliance with the regulatory requirements. The role is responsible for CE marking (EU MDR) and Notified Body change notifications for our dental 2D and 3D imaging products. Senior RA 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.
As a Senior Regulatory Affairs Manager you will be responsible for developing and maintaining regulatory processes and tools, and attending regulatory audits as necessary.
You will report to Senior Regulatory Affairs Manager of KaVo Imaging Business Unit.
We expect you to
hold an Engineering, Business or equivalent degree
have experiences with EU MDR, US FDA, Health Canada, China NMPA registrations and regulatory requirements
have demonstrated knowledge of EU and US UDI regulations
have knowledge of applicable IEC and ISO standards and a passion to learn also national and international x-ray standards
have fluent communication skills both in Finnish and English
Additionally, the following will be considered an advantage:
knowledge of MDSAP program
experiences with implementing requirements for Material Safety and Restrictions (Biocompatibility, RoHS, SCIP, Cal Prop 65)
drive for the application of Lean methodology and processes
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 healthtech 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 where the R&D center for KaVo dental 3D imaging resides. The role allows working remotely, especially when working with the regional RA teams.
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!
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including KaVo, Kerr, Nobel Biocare, Implant Direct and Ormco, partner with dental professionals to help them deliver the best possible patient care.
Envista separated from Danaher as an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .
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