Talent.com
Principal Regulatory Affairs Specialist (Business Partnerships).

Principal Regulatory Affairs Specialist (Business Partnerships).

AbbottAlameda, CA, US
30+ days ago
Job type
  • Full-time
Job description

Principal Ra Specialist Business Partnerships

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to :

  • Career development with an international company where you can grow the career you dream of.
  • 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.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Principal RA Specialist Business Partnerships will work on-site out of our Alameda, CA location in the Diabetes Care Division. We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes. This is an exciting opportunity with responsibilities related to new strategic business initiatives globally, which include breakthrough advancement in diabetes management and digital health technology solutions to address the spectrum of customer needs.

Projects will focus on driving the regulatory strategy for business partnership initiatives involving Cloud / Sensor based external partnerships. The individual has department level influence with experience in global regulatory submissions and on-market changes, and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory compliance strategy, and provide executive management with regulatory metrics / information.

What You'll Work On

  • 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.
  • Required Qualifications

  • 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 Qualifications

  • 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.
  • The base pay for this position is $98,000.00 $196,000.00. In specific locations, the pay range may vary from the range posted.

    Create a job alert for this search

    Regulatory Specialist • Alameda, CA, US

    Related jobs
    • Promoted
    Principal Regulatory Affairs Specialist

    Principal Regulatory Affairs Specialist

    Katalyst Healthcares & Life SciencesSan Francisco, CA, US
    Full-time
    Responsibilities : Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related ...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Specialist II

    Regulatory Affairs Specialist II

    Katalyst Healthcares & Life SciencesAlameda, CA, US
    Full-time
    Responsibilities include developing regulatory strategies, reviewing design input / output documentation, identification of applicable standards and guidance documents, performing regulatory assessme...Show moreLast updated: 30+ days ago
    • Promoted
    Principal Regulatory Affairs Specialist APAC - Diabetes Care (on-site)

    Principal Regulatory Affairs Specialist APAC - Diabetes Care (on-site)

    AbbottAlameda, CA, US
    Full-time
    Principal Regulatory Affairs Specialist APAC.This position will work on-site at our Alameda, CA location in the Diabetes Care Division. We're focused on helping people with diabetes manage their he...Show moreLast updated: 1 day ago
    • Promoted
    Regulatory Affairs Specialist - Ion

    Regulatory Affairs Specialist - Ion

    IntuitiveSunnyvale, CA, US
    Full-time
    Regulatory Affairs Specialist - Ion.At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we e...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs CMC Director

    Regulatory Affairs CMC Director

    ExelixisAlameda, CA, United States
    Full-time
    Provide Regulatory Affairs CMC expertise and leadership for global commercial and development projects.Develop strategic approaches to enable succesful Health Authority submissions and communicatio...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)

    Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)

    AbbottAlameda, CA, US
    Full-time
    At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Career development with an international company where you can grow th...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Analyst I

    Regulatory Affairs Analyst I

    VirtualVocationsConcord, California, United States
    Full-time
    A company is looking for a Regulatory Affairs Analyst I.Key Responsibilities Manage the intake, documentation, and resolution of customer complaints Coordinate with cross-functional teams to gat...Show moreLast updated: 3 days ago
    • Promoted
    Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)

    Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)

    AbbottAlameda, CA, US
    Full-time
    At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Career development with an international company where you can grow th...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Specialist II

    Regulatory Affairs Specialist II

    AbbottAlameda, CA, US
    Full-time
    At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Career development with an international company where you can grow th...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Fladger AssociatesFoster City, CA, US
    Full-time
    Excellent employment opportunity for a Regulatory Affairs Manager in the Foster City, CA area.Seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role require...Show moreLast updated: 16 hours ago
    • Promoted
    Senior Director, Regulatory Affairs

    Senior Director, Regulatory Affairs

    VirtualVocationsSan Francisco, California, United States
    Full-time
    A company is looking for a Senior Director, Regulatory Combination Product.Key Responsibilities Develop comprehensive strategies for biologic and device components aligned with corporate goals an...Show moreLast updated: 2 days ago
    • Promoted
    • New!
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Pacer GroupSan Mateo, CA, US
    Full-time
    Job Title : PRC Submission Management Lead.Location : Foster City, CA 94404 (Hybrid).Seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role requires deep expe...Show moreLast updated: 16 hours ago
    • Promoted
    Director of Regulatory Affairs, Business Excellence

    Director of Regulatory Affairs, Business Excellence

    Bayside SolutionsFremont, CA, US
    Full-time
    Director of Regulatory Affairs, Business Excellence.Redwood City, CA - Remote Role.The Director of Regulatory Affairs - Business Excellence role provides strategic operational support to the Head o...Show moreLast updated: 2 days ago
    • Promoted
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Calyxo, Inc.Pleasanton, CA, United States
    Full-time
    The company was founded in 2016 to address the profound need for improved kidney stone treatment.Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resourc...Show moreLast updated: 6 days ago
    • Promoted
    Associate Director Regulatory Affairs

    Associate Director Regulatory Affairs

    Trebla TalentHayward, CA, US
    Full-time
    Associate Director, Regulatory Affairs.Senior Director, Regulatory Affairs.AD-level regulatory strategists with a strong understanding of US / EU regulatory requirements to support global IND / CTA sub...Show moreLast updated: 2 days ago
    • Promoted
    Director / Sr Director of Regulatory Affairs Lead

    Director / Sr Director of Regulatory Affairs Lead

    Fortvita BiologicsPalo Alto, CA, US
    Full-time
    Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), b...Show moreLast updated: 1 day ago
    • Promoted
    Senior Regulatory Affairs Specialist

    Senior Regulatory Affairs Specialist

    StrykerFremont, CA, US
    Full-time
    Senior Regulatory Affairs Specialist.Join Stryker's Neurovascular Division in Fremont, CA as a Senior Regulatory Affairs Specialist. At Stryker, we're driven by a mission to "Make Stroke History.Our...Show moreLast updated: 18 days ago
    • Promoted
    Director of Regulatory Affairs

    Director of Regulatory Affairs

    Connect Life ScienceFremont, CA, US
    Full-time
    Senior Director of Regulatory Affairs.Hybrid working - some travel to Bay Area.Medical Devices – Class III.Competitive compensation + strong benefits. Director of Regulatory Affairs.US and a p...Show moreLast updated: 1 day ago