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Abbott · 4 months ago

Principal Regulatory Affairs Specialist (Business Partnerships).

Alameda, CA

Full-time

Onsite

Senior Level, Lead/Staff

$98K/yr - $196K/yr

5+ years exp

Abbott is a global healthcare leader focused on helping people live healthier lives, particularly those with diabetes. The Principal Regulatory Affairs Specialist will develop global regulatory strategies, provide technical leadership, and ensure compliance for innovative diabetes management products and partnerships.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

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

Create project plans and timelines

Support functional groups in the development of relevant data to complete a regulatory submission

Write and edit technical documents

Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions

Review and approve labeling to ensure compliance

Monitor emerging issues and identify solutions

Negotiate internally and externally as regulatory liaison

Evaluate regulatory risks of corporate policies

Oversee processes & improvements involved with Partnership regulatory activities

Ensure compliance with product post-marketing approval requirements

Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events

Actively contribute to the development and functioning of the crisis/issue management program

Analyze product-associated problems and develop proposals for solutions

Provide regulatory input for product recalls and recall communications

Qualification

Regulatory submissionsMedical device regulationsRegulatory Affairs CertificationQuality Systems standardsClinical investigationsProject managementCommunication skillsProblem-solvingTeam collaborationAttention to detail

Required

Bachelor's Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)

Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices

Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)

Preferred

5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus

Experience with 510(k) applications, PMA supplements, US device regulations, and/or with EU and other international medical device regulations and submissions

Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical investigations, ICH guidelines

Experience with word processing, spreadsheet and presentation graphic software packages

Experience working in a broader enterprise/cross-division business unit model

Ability to work in a highly matrixed and geographically diverse business environment

Ability to work within a team and as an individual contributor in a fast-paced, changing environment

Ability to leverage and/or engage others to accomplish projects

Ability to identify, solve problems, and work independently with little oversight

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Multitasks, prioritizes, and meets deadlines in a timely manner

Strong organizational and follow-up skills, as well as attention to detail

Ability to travel approximately 5%, including international travel

Benefits

Career development with an international company where you can grow the career you dream of.

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.