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 2'600 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.Ensure reporting to the manager or ESH responsible person of ESH deficiencies and hazards (affecting working materials and funds as well as the working environment) which cannot be self-rectifiedCompleted studies, ideally in the field of medical technology or life sciencesAt least 3 years of professional experience on global / international level in regulatory affairs in the medical device environmentExpert knowledge of the regulatory requirements MDD/MDR, FDA, 21 CRF 820, CMDR, ISO 13485Good command of communication in English (written and spoken), German knowledge - advantageYou are an assertive, communicative personality and an organizational talentYour are independent professional, with structured way of workingAbility to travel (up to 10%)Opportunity for your developmentGreat team and working atmospheremedmix is an equal opportunity employer, committed to the strength of a diverse workforce.93% of our employees would go above and beyond to deliver results – do you have the drive to succeed? Join us and boost your career, starting today!#J-18808-Ljbffr
