Global Regulatory Strategy Lead, Medical Devices

Acist Medical Systems Inc.; Eden Prairie (MN); Presencial; USD 132.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Paid time off

Company holidays

Paid family leave

Retirement savings

Tuition reimbursement

Professional development opportunities

Descripción de la vacante

Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist to develop and implement regulatory strategies across projects and products, partnering with internal and external stakeholders to optimize submissions and maintain approvals. The role covers 510(k), EU MDR, and Health Canada submissions, global registrations, and regulatory leadership across the product lifecycle.

Expect minimal travel and a focus on crossing regulatory milestones with digital tooling.

Formación

• Minimum Bachelor’s degree plus 7+ years of experience in medical device Regulatory Affairs.
• Demonstrated experience with 510(k), EU CE Marking, and Health Canada submissions.
• Understanding of FDA, EU MDD and MDR, Australia and Canada regulatory framework.
• Experience leading FDA meetings, such as pre-submissions and submission issue requests.
• Effective written and verbal communication skills, technical writing and editing skills.
• Ability to develop clear, concise, and timely oral and written reports for diverse audiences.
• Proficiency with digital productivity and generative AI tools to support document development, data analysis, and process efficiency.

Responsabilidades

• Develop and execute regulatory plans including 510(k) and EU MDR submissions.
• Coordinate cross-functional support for worldwide registrations for global product growth.
• Represent regulatory on project teams throughout the product lifecycle.
• Lead meetings with government authorities (FDA) and support audits.
• Mentor junior staff and provide regulatory guidance to partners.
• Leverage AI tools to improve efficiency and ensure compliance.

Conocimientos

Regulatory strategy

FDA meetings experience

Cross-functional collaboration

Technical writing

AI tools usage

Educación

Bachelor’s degree in science/engineering

RAC Certification

Herramientas

Microsoft 365 Copilot

Descripción del empleo

Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist to develop and implement regulatory strategies across projects and products, partnering with internal and external stakeholders to optimize submissions and maintain approvals. The role covers 510(k), EU MDR, and Health Canada submissions, global registrations, and regulatory leadership across the product lifecycle.

Expect minimal travel and a focus on crossing regulatory milestones with digital tooling.