Regulatory Affairs Specialist - Medical Devices

Regulatory Affairs Specialist - Medical Devices

Baxter International

Munich, Germany

Your tasks:

• Provide regulatory input to product lifecycle planning and new product development mainly for surgical lights;
• Act as Global Regulatory Lead for surgical lights and work with Country Regulatory colleagues for international registrations of the surgical lights;
• Ensure compliance with regulations (21 CFR 820, MDR), standards (ISO 13485, product specific standards), and the quality manual;
• Work closely with product development, clinical, quality 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);
• Create GSPRC, STEDs and review TD documents, including Clinical Evaluation reports, labeling, advertising, promotion and marketing literature;
• Monitor international applications;communicate the progress to internal stakeholders;
• Ensure compliance with product post-marketing approval requirements;
• Provide regulatory input for product recalls, recall communications, and CAPAs, (where necessary);
• Support change control activities;
• Provide MDR updates/guidance to product development teams.

Your profile:

• Completed academic education in a related medical, scientific, engineering services, or regulatory discipline isrequired;
• Minimum of 3 years' experience in creating and managing international regulatory submissions for Medical Devices (Active medical devices of Class I & II preferred);
• Global registration experience for medical devices, limited experience with US 510(k) submission and experience in reviewing technical documents, Project Management; skills and experience, ideally with supporting new product developments and launches;
• Strong proficiency with Microsoft systems (Excel, PowerPoint, and Word and Teams);
• Strong attention to detail as well as strong questioning and listening skills;
• Good planning and organizational skills;
• Strong internal customer service orientation with “do whatever it takes” attitude;
• Excellent English communication skills are mandatory; good German knowledge is a plus;
• Ability to work in cross-functional teams with people from various disciplines and cultures.

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