.Senior Regulatory Affairs Specialist (m/f/d)Full-timeBusiness Segment: Operationsmedmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2'700 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). www.Medmix.SwissJob purposeCompliance with regulatory, legal and normative requirements for SMS. Review and cooperation in the preparation of the technical documentation. Ensuring product approval in accordance with country-specific regulations.Main accountabilities and tasksObservation and management of standards and directives, information on changesParticipation in system maintenance of ISO 13485Assisting in the implementation of the requirements of authorities, directives, customers and standardsTechnical clarification and assessment of customer and authority requirements.Preparation and maintenance of system documentation.Technical documentation of customer and own projects, checking and cooperation in completeness and technical correctness before and during the preparation of evidence as well as before its archiving.Cross-site technical expert for assigned technical documentation topics.Cross-location expert for country requirements for assigned regionsImplementation of worldwide product approvalsCollaboration in the creation of customer contracts, such as delivery agreements.Support of the line offices in the creation of specification, template and proof documents.Collaboration and support of the medical device manager for medical device topics.Cooperation and support of the lines with medical device and industrial product topics.Contact to authorities, e.G. for inquiries, registrations and certifications.Duty to report to superiors, situatively to the line, in case of violation of legal compliance in medical devices issues.Ensuring the technical correctness of results and recommendations.Obligation to report via application procedure to superior, to CIP, misconduct of line offices, deficiencies in projects, etc.Preparation and implementation of specialist employee training (GMP, hygiene, standards, etc.).Participation and performance of internal audits.Ensure compliance with laws and regulations regarding environmental protection, fire prevention as well as occupational health and safety
