Job Description:

Matricel GmbH headquartered in Herzogenrath (Germany) was aquired by Nobel Biocare in 2020, a part of Envista Holdings headquartered in Brea, California (USA). Matricel GmbH is a fast growing, successful biomedical company with worldwide activities. We develop, produce and distribute innovative medical devices for clinical applications in the regenerative medicine.

Primary duties & responsibilities:

• Coordination of projects to implement new regulatory requirements (i.e. MDR (EU) 2017/745) and supporting other departments to comply with these regulatory requirements

• Supporting development projects for RA aspects, creating development-related and technical documentation for medical devices, editing existing technical documentation

• Communicate and work with national and international Regulatory Affairs agencies

• Support the development of national and international regulatory strategies

• Initiate and implement projects for new or updated regulatory requirements to ensure continuous market access

#LI-EU1

Job Requirements:

• Master or comparable academic degree in Biomedical Science, Chemistry, Pharmacy, Natural Science or equivalent

• Minimum 3 years´ experience as Regulatory Affairs Specialist in the field of medical technology, preferably in an international context

• In-depth knowledge of standards and regulations such as: ISO 13485, ISO 14971, 21 CFR part 820, MDSAP, MDR, international approval requirements

• Experience in registration of medical devices in Japan would be an advantage

• Creation and updating of plans & reports according to MDR (e.g. SSCP reports, PSUR)

• Languages: Fluent in English, both in conversation as well as in writing. German is an advantage.

Operating Company:

Nobel Biocare

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 DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.

Envista became 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 .