Senior Regulatory Affairs Director - Medical Devices

Thornton Tomasetti; Alameda (CA); On-site; USD 149,000 - 297,000; Full time

Benefits offered by this job

Career development

Health coverage

Retirement plan

Tuition reimbursement

Job summary

Abbott in Alameda, CA is seeking an Associate Director Regulatory Affairs to shape global regulatory strategies across the product life cycle in Diabetes Care. We focus on innovative glucose monitoring technologies and drive strategic regulatory initiatives.

You will lead and develop high-performing teams, interface with agencies, and drive regulatory submissions for US and EU, ensuring compliance and timely approvals.

Qualifications

• Bachelor's degree in a regulated field or related area.
• 5-7 years’ experience in a regulated industry (e.g., medical products).
• 5-7 years’ experience in regulatory preferred but may consider QA, R&D/support, scientific affairs, operations, or related area.

Responsibilities

• Develop global regulatory strategies for product development and planning throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Provide technical leadership and strategic input on complex issues and to business units.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Develop and communicate a vision for the organizational unit assigned.
• Create project plans and timelines.
• Lead functional groups in the development of relevant data to complete a regulatory submission.

Skills

Regulatory affairs expertise

Cross-functional collaboration

Regulatory submissions

Communication skills

Education

Bachelor's degree

M.S. in technical area or MBA is preferred

Ph.D. in a technical area or law is helpful

RAC certification

Job description

Abbott in Alameda, CA is seeking an Associate Director Regulatory Affairs to shape global regulatory strategies across the product life cycle in Diabetes Care. We focus on innovative glucose monitoring technologies and drive strategic regulatory initiatives.

You will lead and develop high-performing teams, interface with agencies, and drive regulatory submissions for US and EU, ensuring compliance and timely approvals.