Senior Regulatory Affairs Manager, Med Device Software (SaMD/SiMD)

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Your Role at Baxter

Regulatory Portfolio Lead responsible for managing the regulatory aspects of complex development programs or an interrelated portfolio of products. 

This position will have direct oversight and accountability for new product development (NPD) and sustaining product support for their assigned portfolio, particularly related to Software as a Medical Device.  This position will be responsible for direct interactions with US and EU regulatory bodies (including CE Marking). 

What you'll be doing

• Provide regulatory input to product lifecycle planning, particularly for standalone software medical devices.
• Determine classification, submission and approval requirements, particularly for standalone software medical devices.
• Assist in the development and update of multi-country regulatory strategies based upon regulatory and product changes, particularly standalone software medical devices.
• Compile, prepare, review and submit regulatory submission(s) to authorities.
• Supervise and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
• Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies.
• Ensure compliance with product post-marketing approval requirements.
• Review and approve advertising and promotional items to ensure regulatory compliance.
• Responsible for compliance with applicable Corporate Policies and procedures.

What you'll bring

• 8+ years experience in a regulated industry (e.g., medical devices, combination products).
• 3+ years of experience working with medical software and its associated regulations (preferred).
• Submission/registration types and requirements.
• Experience understanding, interpreting and applying regulations and standards (GxPs (GCPs, GLPs, GMPs), ISO 13485, IEC 62304).
• EU Medical Device Directive and EU Medical Device Regulation.
• Domestic and international regulatory guidelines, policies and regulations, particularly as applied to standalone software.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. #LI-ASR2
 

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Prestaciones en Estados Unidos en Baxter (excepto Puerto Rico)

Aquí es donde tu bienestar importa. Baxter ofrece paquetes integrales de compensación y beneficios para roles elegibles. Nuestros beneficios de salud y bienestar incluyen cobertura médica y dental que comienza desde el primer día, a