Regulatory Affairs & Quality Manager (m/f) - Medical Devices
Surface Solutions Segment | Munich
We are looking for a Regulatory Affairs & Quality Manager (m/f) – Medical Devices based in Munich (Germany). As part of the new Additive Manufacturing Business Unit, you will report to the Director Group Strategy Development. You will be responsible for ensuring regulatory compliance of Business Unit Additive Manufacturing (BU AM) in all activities related to the Medical Devices segment. BU AM offers AM services including development and contract manufacturing of metal AM medical devices including orthopaedic implants and instruments. As an Oerlikon group subject expert the position is expected to interact with other business units such as for coating on similar topics.
- Identify regulatory requirements worldwide and relevant standards for medical devices and processes in scope of BU AM and other BUs of Oerlikon group
- Handle registrations, certifications and communications with regulatory authorities as well as submissions of master files to FDA
- Define and coordinate alignment in quality management systems between various ISO 13485 certified facilities worldwide
- Collaborate with local Quality Managers to develop consistent procedures such as for risk management and supplier management
- Collaborate with R&D and manufacturing functions in various business units to define technical files and to guarantee compliance in all development and manufacturing activities such as verification and validation plans
- Collaborate with application engineers and OEM customers to define regulatory requirements, strategies and plans, as well as technical documentations in OEM projects
- Train application engineers and local quality managers on changes in regulatory requirements
- Plan audit programs for ISO 13485 facilities and sub-contractors
- Participate in manufacturing audits (regulatory authorities, customers and internal)
- University degree in engineering or equivalent discipline
- Significant (5+ years’) experience Regulatory Affairs & Quality Management for Medical Devices
- Minimum of 3 years of management experience
- Experience with GMP, QSR and ISO compliance and specific expertise in manufacturing quality and process validation
- Experience with FDA, Health Canada, MDD/MDR and MHLW/PMDA regulations and compliance
- Regulatory experience in medical devices with Class I, II, and III in the US; class IIa, IIb and III in Europe, or Class II, III, IV products for other global markets highly preferred.
- Outstanding interpersonal skills, self-driven, open and positive mind set with experience in international and cross-cultural business environment, entrepreneurial mind set
- Fluent English (verbal and written); German is advantageous; other languages beneficial
- Flexible to occasional travel internationally (up to 50 percent)
- Become a leader in an industry that is revolutionizing manufacturing
- Experience a startup environment within a leading global technology group
- Be part of an agile, innovative and passionate team
- Accelerate your career in a growing business unit
- Join a global cross-cultural and collaborative workplace
Why Additive Manufacturing?
We see Additive Manufacturing as a game changer in many industries over the next years and our ambition is to become the leading integrated provider of materials, design expertise and production service for advanced metal AM components.
- Advertised Since
Import as VCF
With your application you agree that your personal data for the purpose of personnel planning and the development of your career will be used by a third party employed by the OC Oerlikon Corporation. In line with the usage of these data access is granted for a third party outside the area of validity of the EG directive. We will take care that your rights according to EG guidelines will be granted within such a further use. Hereby we inform you that you have the right/request of information about the further use as well as about content and structuring of your personal data. You can recall your agreement at any time.