Abbott Laboratories

Regulatory Affairs Manager – Vascular (on-site)

United States - California - Santa Clara

Sponsorship not specified$114k-$228kDetected 12 days ago

Product ManagementEmbedded SystemsPharmacologyFDA RegulatoryMedical DevicesResearchAnimal StudiesLeadershipRegulatory Affairs

About the role

Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

Develop new regulatory policies, processes and SOPs and train key staff on them. Evaluate regulatory risks of division policies, processes, procedures.
Support pre and post approval clinical strategy and submission activities
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
Execute and manage technical and scientific regulatory activities. Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met
Develop new regulatory policies, processes and SOPs and train key staff on them.
May lead a cross-functional or cross-divisional project team

Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Master's or Ph.D. in a technical area
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions
Ability to define regulatory strategy.
Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
Experience with post-approval manufacturing and design changes
Ability to work effectively on cross-functional teams
Strong attention to detail

Abbott is a global healthcare leader that helps people live more fully at all stages of life.
Our 115,000 colleagues serve people in more than 160 countries.

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree
Bachelor's Degree in a related field OR an equivalent combination of education and work experience
Minimum 4 years' experience in a regulated industry (e.g., medical products, nutritionals).

This listing is sourced directly from Abbott Laboratories's careers page and normalized into a canonical job model.