Senior Specialist Regulatory Affairs (f/m/d)

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Baxter Medical Systems enables peak procedural performance and connectivity across all care environments. From Emergency Care, Surgical Care, to Intensive Care and Med-Surge Care our solutions deliver real-time insights and 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. Baxter takes this development into account and sets new standards with its intelligent and networked solutions.

For our Regulatory Affairs Team, we are now hiring a

Senior Specialist Regulatory Affairs (f/m/d)

based in Munich (remote option).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide regulatory input to product lifecycle planning and new product development mainly for Surgical tables / OR tables

• Generate 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 pre-approval 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

EDUCATION AND EXPERIENCE:

• Completed academic education in a related medical, scientific, 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 devices.

• Global registration experience for medical devices, good experience with US 510(k) submission and experience in reviewing technical documents

• 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 are mandatory; good German knowledge is a plus

• Ability to work in cross-functional teams with people from various disciplines and cultures

What we offer:

A development opportunity for you and a chance to work in a highly diverse and experienced team with a great mix of people. Joining Baxter means joining a team that you can truly learn from while having fun! You will gain excellent exposure and fantastic industry knowledge within healthcare working for a global organization with strong presence in Germany.

What's next:

If you like the sound of the above role and if this position resonates with you, then we’d love to talk to you. Please apply directly through our Online System. For additional information, please reach out to [email protected].

#LI-REMOTE

#IND-DACH

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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