Senior Regulatory Affairs Specialist - California, United States - enVista

enVista California, United States

3 weeks ago

Description

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.

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