Senior Regulatory Strategist, Medical Devices

Acist Medical Systems Inc.; Eden Prairie (MN); In loco; USD 131.000 - 143.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

Paid time off

Company holidays

Paid family leave

Retirement savings

Tuition reimbursement

Professional development opportunities

Descrizione del lavoro

Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist in the United States to develop and execute regulatory strategies for medical device products, submissions, and lifecycle changes.

The role provides hands-on regulatory support for new product marketing submissions, changes to existing devices, global registrations, audits, labeling, and ongoing compliance with applicable regulations and company standards.

Competenze

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs or a related field.
• 7+ years of regulatory affairs experience in the medical device industry.
• Demonstrated experience preparing and supporting global regulatory submissions, including FDA 510(k), EU MDR/CE Marking, and Health Canada submissions.
• Strong understanding of FDA regulations, EU MDR, international regulatory frameworks, labeling review, and regulatory compliance practices.

Mansioni

• Develop and execute regulatory plans for product submissions including 510(k) and MDR/CE labeling.
• Serve as regulatory lead on cross-functional project teams across the product lifecycle.
• Prepare for and support communications with regulatory agencies and Notified Bodies, including FDA interactions and audits.
• Maintain complete regulatory files and product registrations with supporting documentation.
• Review labeling, advertising, and promotional materials for regulatory compliance.
• Monitor regulatory changes and advise on impact and actions.
• Mentor junior staff and support cross-functional partners.

Conoscenze

Regulatory affairs

FDA submissions

Project leadership

Technical writing

Cross-functional collaboration

Formazione

Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs

Strumenti

FDA 510(k)

EU MDR/CE Marking

Health Canada submissions

Descrizione del lavoro

Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist in the United States to develop and execute regulatory strategies for medical device products, submissions, and lifecycle changes.

The role provides hands-on regulatory support for new product marketing submissions, changes to existing devices, global registrations, audits, labeling, and ongoing compliance with applicable regulations and company standards.