Senior Specialist Regulatory (m/f/d)

Unternehmen	TRUMPF Medizin Systeme GmbH + Co. KG (Puchheim)
Ihre Aufgabe	Provide regulatory input to new product development and product lifecycle planning Generation of documentation and procedures relating to product development, manufacturing, and quality control in accordance with regulatory standards Ensure compliance with regulations (21 CFR 820), standards (ISO 13485), and the quality manual Work closely with product development, clinical, and marketing teams to gain required information for new product submissions and provide regulatory advice to project teams as required (Example: DHF/Technical Documentation maintenance) Review documents, including Clinical Evaluation reports, risk analysis, FMEA, reports, labeling, advertising, promotion and marketing literature Assist with document control, including document review, approval, archiving, maintenance of document list, and working with other functional groups on development of new processes or procedures Maintain regulatory files in a format consistent with requirements Assess the acceptability of quality, preclinical and clinical documentation for regulatory submission filing Monitor applications under regulatory review Communicate application progress to internal stakeholders Communicate preapproval compliance activities Ensure compliance with product post-marketing approval requirements Ensure external communications meet regulations Identify emerging issues Provide regulatory input for product recalls, recall communications, and CAPAs, (where necessary) Provide MDR updates/guidance to product development teams
Ihr Profil	Completed academic education in a related medical, science, engineering services, or regulatory discipline required Minimum of 5 years experience in creating and managing international regulatory submissions for Medical Devices (Class I & II preferred) or more than 10 years in the medical device industry or related GMP environment or equivalent Specific medical device experience, particularly with Class I and Class II software and/or hardware developed devices. Project Management Experience, ideally with supporting new product developments and launches Strong proficiency with Microsoft systems (Excel, PowerPoint, and Word) Strong attention to detail as well as strong questioning and listening skills Good planning and organizational skills and the ability to organize and track complex information Analytical and problem-solving skills Strong internal customer service orientation with “do whatever it takes” attitude Excellent English communication skills and good German knowledge are required Ability to work in cross-functional teams with people from various disciplines and cultures Review technical documents
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	TRUMPF Medizin Systeme GmbH + Co. KG (Puchheim)
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