Sr. Specialist, Medical Affair

Zvh; Raleigh (NC); On-site; USD 104,000 - 143,000; Full time

Job summary

Join a forward-thinking company dedicated to saving lives through innovative medical solutions. As a Senior Specialist in Medical Affairs, you will play a crucial role in supporting new product development and ensuring compliance with healthcare regulations. Your expertise will guide product development, and your collaboration with diverse teams will enhance patient care. This role offers the chance to make a significant impact in a dynamic environment while enjoying flexible work policies that promote work-life balance. If you're passionate about making a difference in healthcare, this opportunity is for you.

Benefits

Health Coverage

401(k)

Stock Purchase Plan

Paid Time Off

Parental Leave

Qualifications

• 3+ years of acute adult clinical experience; industry experience preferred.
• Degree in nursing or related clinical field with relevant experience.

Responsibilities

• Serve as the medical resource for product development and support.
• Develop medical input for technical documents and regulatory compliance.
• Collaborate with Clinical SMEs and support Clinical Evaluators.

Skills

Problem-Solving

Teamwork

Organizational Skills

Interpersonal Communication

Medical Writing

Education

Degree in Nursing

Nursing Informatics

Job description

Sr. Specialist, Medical Affair page is loaded

Sr. Specialist, Medical Affair

Apply locations Raleigh, North Carolina | time type Full time | posted on Posted 2 Days Ago | time left to apply End Date: May 16, 2025 (4 days left to apply) | job requisition id JR - 172248

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.

Your Role at Baxter

Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. Our mission is to save and sustain lives. Our global Healthcare Systems and Technology (HST) segment includes Front Line Care (FLC), Patient Support Systems (PSS), Global Surgical Solutions (GSS), and Connected Care Group, focusing on innovation for smarter, personalized patient and provider care. We aim to expand Baxter’s impact across healthcare, supported by our new product pipeline.

The Senior Specialist supports New Product Development (NPD) and Sustaining activities within the product portfolio, providing expertise on medical devices and healthcare software regulatory requirements (e.g., EU MDD, MDR). The role requires global and regional clinical knowledge, guidance for product development, and support for Subject Matter Experts (SMEs) and Clinical Evaluators.

What you'll be doing

• Serve as the medical/clinical resource for internal and external stakeholders for product development and support.
• Develop and deliver medical/clinical input for technical documents, claims, risk assessments, and EU MDD/MDR compliance.
• Collaborate with Clinical SMEs, R&D, Marketing, and Medical Affairs for evidence generation, literature searches, and regulatory compliance.
• Participate in EU MDD/MDR core team meetings and support Clinical Evaluators.
• Maintain knowledge of Baxter Care Communication products and other duties as assigned.
• Demonstrate clinical proficiency related to products.
• Contribute to risk documentation, testing, claims development, gap analysis, and evidence generation planning.
• Provide medical writing support for EU MDD/MDR deliverables (e.g., CER, PMCF, SSCP) in collaboration with DPMs.
• Support medical writing for evidence generation projects (e.g., studies, white papers, publication plans).
• Assist with legal, regulatory, and quality requirements throughout R&D and product lifecycle.

What you'll bring

• Degree in nursing, nursing informatics, or related clinical field with relevant experience.
• At least 3 years of acute adult clinical experience; industry experience preferred.
• Specialty certification preferred, especially in digital health, nursing informatics, or related areas.
• Active U.S. license in good standing.
• Willingness to travel domestically and internationally up to 50%.
• Strong problem-solving, teamwork, and organizational skills in a fast-paced environment.
• Scientific clinical approach to medical writing, with technical and clinical credibility.
• Self-motivated with excellent time management and multitasking skills.
• Exceptional interpersonal and communication skills, with experience working across cultures.

Applicants must be authorized to work in the U.S. without sponsorship.

Baxter offers flexible work policies, including minimum onsite days, to support collaboration and work-life balance.

Compensation and Benefits

The estimated base salary range is $104,000-$143,000 annually, based on location, skills, and experience. The role may be eligible for bonuses. For more details, speak with the recruiter.

US Benefits at Baxter

Our benefits include health coverage, insurance, 401(k), stock purchase plan, paid time off, parental leave, and more. Visit our Benefits site for details.

Equal Employment Opportunity

Baxter is an equal opportunity employer. We evaluate applicants without discrimination based on legally protected characteristics.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

We provide accommodations for individuals with disabilities. Contact us if needed.

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