Regulatory Affairs Leader - Medical Devices & FDA Strategy

Thornton Tomasetti; Alameda (CA); Presencial; USD 114 000 - 228 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health Insurance

Tuition reimbursement

FreeU education benefit

Freedom 2 Save student debt program

Great place to work

Resumo da oferta

Abbott is hiring a Regulatory Affairs Manager to lead U.S. regulatory strategy for new products and lifecycles, while mentoring a team of regulatory professionals across R&D, quality, and commercial teams in Alameda/Milpitas/Austin.

The role emphasizes interaction with FDA pathways, ensuring compliance, and driving timely submissions. A strong background in regulatory guidelines and cross-functional collaboration is essential.

Qualificações

• Bachelor's Degree in a related field or equivalent combination of education and work experience.
• Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals).
• 2-5 years of experience in regulatory preferred but may consider QA, R&D/support, scientific affairs, operations, or related area.
• Ability to effectively communicate verbally and in writing with diverse audiences.
• Domestic and international regulatory guidelines, policies and regulations.
• Lead functional groups in developing data for regulatory submissions.

Responsabilidades

• Drive U.S. regulatory strategy for new products and lifecycle management.
• Lead and mentor a team of regulatory professionals, fostering collaboration and high performance.
• Partner cross-functionally with R&D, clinical, quality, and commercial teams to influence product development.
• Drive FDA pathways, submissions, and interactions (pre-submissions, 510(k), PMA, post-market).
• Negotiate with regulatory authorities to ensure timely approval.
• Ensure compliance excellence balancing speed to market with standards.
• Anticipate regulatory obstacles and propose cross-functional solutions.
• Execute and manage technical and scientific regulatory activities.
• Function independently as a decision-maker on regulatory issues.

Conhecimentos

Regulatory strategy

FDA pathways

Leadership/mentoring

Cross-functional collaboration

Regulatory guidelines

Communication (verbal & written)

Formação académica

Bachelor's Degree in related field

Equivalent combination of education and work experience

Descrição da oferta de emprego

Abbott is hiring a Regulatory Affairs Manager to lead U.S. regulatory strategy for new products and lifecycles, while mentoring a team of regulatory professionals across R&D, quality, and commercial teams in Alameda/Milpitas/Austin.

The role emphasizes interaction with FDA pathways, ensuring compliance, and driving timely submissions. A strong background in regulatory guidelines and cross-functional collaboration is essential.