Senior Regulatory Operations Specialist

1 week ago

Alameda, California, United States Abbott Laboratories company Full time
Abbott is a global healthcare leader that helps people live more fully at all stages of life.

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.

Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott


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 for employees via the Health Investment Plan (HIP) PPO
  • 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
This Senior Regulatory Operations Specialist will work 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.

The Opportunity


As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.

The individual may execute tasks and play a consultative role by partnering across business functions.

The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of digital products worldwide.

The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. This is an exciting opportunity to work in the dynamic and evolving digital health space.

What You'll Work On

  • As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
  • The individual may execute tasks and play a consultative role by partnering across business functions.

  • The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of digital products worldwide.

  • The individual may prepare documentation needed for registration worldwide or may oversee such preparation.
  • Provide regulatory input to digital product lifecycle planning.
  • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
  • Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
  • Determine trade issues to anticipate regulatory obstacles.
  • Determine and communicate submission and approval requirements.
  • Participate in risk-benefit analysis for regulatory compliance.
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
  • Compile, prepare and review regulatory submission to authorities.
  • Monitor impact of changing regulations on submission strategies.
  • Monitor applications under regulatory review.
  • Monitor and submit applicable reports to regulatory authorities.
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
  • Negotiate and interact with regulatory stakeholders during the development and review process to ensure submission approval.
  • Assist compliance with product post-marketing approval requirements.
  • Assess external communications relative to regulations.
  • Review regulatory aspects of contracts.
  • Assist with label development and review for compliance before release.
  • Submit and review change controls to determine the level of change and consequent submission requirements.
  • Analyze the input of cumulative product changes to current product submissions.
  • Contribute to the development and functioning of the crisis/ issue management program.
  • Ensure product safety issues and product associated events are reported to regulatory agencies.
  • Provide regulatory input for product recalls and recall communications.
Required Qualifications

  • Bachelor's degree (or equivalent);
  • 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • 3-4 years' experience in a regulated industry (e.g., medical products, nutritionals).

Note:
Higher education may compensate for years of experience.

  • Knowledge of principles and requirements of applicable product laws
  • Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs)
  • Domestic and international regulatory guidelines, policies and regulations
  • Ethical guidelines of the regulatory profession, clinical research and regulatory process
  • Pay strong attention to detail, manage projects and create project plans and timelines.
  • Think analytically, organized and track complex information.
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Has broad knowledge of various technical alternatives and their potential impact on the business. Use in-depth knowledge of business functions and cross group dependencies/ relationships
  • Define regulatory strategy with supervision
  • Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
Preferred Qualifications

  • Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
  • Advanced degree in Engineering, Sciences, or related discipline
  • Ability to work effectively on cross-functional teams
  • Strong written, verbal and presentation skills
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Apply Now

  • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:


Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at , on Facebook at and on Twitter @AbbottNews.
Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.


The base pay for this position is $83, $167, In specific locations, the pay range may vary from the range posted.

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