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Regulatory Operations Specialist III â Digital Health Technologies
1 month ago
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. Youâll 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 bachelorâs 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 Regulatory Operations Specialist III will work on-site at our Alameda, CA location in the Diabetes Care Division. Weâre focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Weâre revolutionizing the way people monitor their glucose levels with our new sensing technology.
The Opportunity
As an individual contributor, the function of a Regulatory Affairs Specialist III 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 Youâll Work On
- As an individual contributor, the function of a Regulatory Affairs Specialist III is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
- May execute tasks and play a consultative role by partnering across business functions.
- 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.
- May 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
- Bachelorâs Degree or an equivalent combination of education and experience
- 5 yearsâ work experience
Preferred Qualifications
- Bachelorâs degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, engineering, etc.
- Advanced degree in Engineering, Sciences, or related discipline
- 5+ yearsâ experience in Medical Device industry
- 1-2 years of regulatory experience.
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing.Â
- Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
- Think analytically with good problem-solving skills.
- 510(k), PMA, or other international regulatory submission experience.
- RAPS Certification.Â
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:Â www.abbottbenefits.com
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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $73,600.00 â $147,200.00. In specific locations, the pay range may vary from the range posted.
