Hillrom Surgical Solutions enable peak procedural performance and connectivity across all care environments. From tables designed for easy setup and precise positioning, to lights that eliminate shadows, to technology that delivers real-time insights, our products help care teams deliver great outcomes. In order for surgical teams and nursing staff to work efficiently, digital systems and automated devices are vital to helping streamline processes, increase user comfort and enhance patient safety. Hillrom takes this development into account and sets new standards with its intelligent and networked solutions.
For our location close to Munich we are looking for a Senior Specialist Regulatory (m/f/d).
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
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
To apply please use the online job application tool on our website jobs.trumpfmedical.com/index including information on your notice period and salary expectations. Please send all documents in English. If you still have questions, please contact Julian Förtsch from the Human Resource Department.