- 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
- 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.
-
Regulatory Affairs Specialist
vor 5 Tagen
Medical Magnesium GmbH Aachen, DeutschlandWir suchen Dich als Regulatory Affairs Specialist zum nächstmöglichen Zeitpunkt · medical magnesium entwickelt metallische bioabsorbierbare Implantate für die orthopädische und unfallchirurgische operative Therapie. Die Implantate sind mechanisch belastbar und werden nach der Fra ...
-
Senior Regulatory Affairs Specialist
vor 13 Stunden
Nobel Biocare Herzogenrath, DeutschlandOperating Company: Nobel Biocare · Location: Herzogenrath,Nordrhein-Westfalen,DE · Date Posted: March 24, 2024 · Req Number: R5019229 · **Primary duties & responsibilities**: · - Coordination of projects to implement new regulatory requirements (i.e. MDR (EU) 2017/745) and suppor ...
-
Regulatory Affairs Specialist
vor 1 Woche
Abiomed Aachen, DeutschlandAbiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: "Patients First." With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employ ...
-
Senior Regulatory Affairs Specialist
vor 2 Tagen
Abiomed Aachen, DeutschlandAbiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 1,800 employees, Abiomed is one of the fastest growing medical technology companies in the world with corpo ...
-
Senior Regulatory Affairs Specialist
vor 1 Woche
Abiomed Aachen, DeutschlandAbiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 1,800 employees, Abiomed is one of the fastest growing medical technology companies in the world with corpo ...
-
Senior Regulatory Affairs Specialist
vor 3 Tagen
Johnson & Johnson Aachen, DeutschlandAbiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: "Patients First." With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,000 employ ...
-
Regulatory Affairs Specialist
vor 1 Woche
BioTalent Aachen, DeutschlandRole: Regulatory Affairs Specialist · Location: Aachen · About Us: This company is a a leading innovator in Medical Device specifically within the area of cardiology specifically manufacturing class II Devices · Key Responsibilities: · Ensure compliance with regulatory requ ...
-
Senior Regulatory Affairs Specialist Germany
vor 6 Tagen
Galderma Mönchengladbach, DeutschlandWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans th ...
-
Associate Director
vor 3 Tagen
Johnson & Johnson Aachen, DeutschlandAbiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world ...
-
Field Clinical Specialist
vor 3 Tagen
Johnson & Johnson Aachen, Deutschland**Field Clinical Specialist - Abiomed**: · **ABIOMED part of Johnson & Johnson, **is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiome ...
-
Medical Science Liaison
vor 3 Tagen
Johnson & Johnson Aachen, Deutschland**Abiomed** is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the w ...
-
Medical Science Liaison
vor 3 Tagen
Johnson & Johnson Aachen, Deutschland**Abiomed** is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the w ...
-
Medical Science Liaison
vor 3 Tagen
Johnson & Johnson Aachen, DeutschlandAbiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world ...
-
Medical Science Liaison
vor 3 Tagen
Johnson & Johnson Aachen, Deutschland**Abiomed **is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the w ...
-
Medical Science Liaison
vor 3 Tagen
Johnson & Johnson Aachen, DeutschlandAbiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world ...
-
Senior Corporate Social Responsibility
vor 3 Tagen
Johnson & Johnson Aachen, DeutschlandAbiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world ...
-
Regulatory Specialist and Senior Specialist
vor 1 Woche
BioTalent Aachen, DeutschlandRole: Regulatory Affairs Specialist Location: Aachen · About Us: This company is a a leading innovator in Medical Device specifically within the area of cardiology specifically manufacturing class II Devices · Ensure compliance with regulatory requirements. · Collaborate with ...
Senior Regulatory Affairs Specialist - Herzogenrath, Deutschland - Matricel GmbH
vor 3 Tagen
Beschreibung
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:
#LI-EU1
Job Requirements:
Operating Company:
Nobel BiocareEnvista 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.
