My client is looking for a Regulatory Affairs & Quality Manager – Medical Devices based in Munich (Germany).
As part of the Additive Manufacturing Business Unit, this position will report to the Director of 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.
· Identify regulatory requirements worldwide and relevant standards for medical devices and processes in scope of BU AM and other Bus.
· 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 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
· Regulatory Affairs & Quality Management for Medical Devices
· Experience with GMP, QSR and ISO compliance and specific expertise in manufacturing quality and process validation
· Experience with FDA, 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.
· Fluent English (verbal and written); German is advantageous; other languages beneficial
· Flexible to occasional travel internationally (up to 50 percent)
What the client can offer
· 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