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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