- 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 bachelors 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.
- Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
- Creates, reviews and approves engineering changes.
- Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
- Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
- May interface directly with FDA and other regulatory agencies.
- Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
- Reviews protocols and reports to support regulatory submissions.
- Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Bachelors Degree or an equivalent combination of education and work experience
- Minimum 3 years related experience, including a minimum of two years regulatory experience
- Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
- 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, manage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Strong organizational and follow-up skills, as well as attention to detail.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Bachelor's degree in science/technical discipline (engineering, life sciences, mathematics).
- Masters degree
- Experience working in a broader enterprise/cross-division business unit model.
- Experience working in the Medical Device industry.
- Regulatory Affairs Professionals Society Certification is a plus.
- Previous experience with 510k / PMA submissions or class I / II exempt software devices
- Knowledge of insulin dosing products and diabetes management solutions
- Previous experience with SaMD, AI/ML, and other digital health technologies
- Familiarity with Predetermined Change Control Plans (PCCPs)
- Working knowledge of FDA QSR
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Regulatory Affairs Specialist Digital Health Technologies - Alameda, United States - Abbott Laboratories company
Description
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. Youll also have access to:
This Regulatory Affairs Specialist will work out of our Alameda, CA location in the Diabetes Care Division. Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.
The Opportunity
As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for product market entry.
What Youll Work On
Required Qualifications
Preferred Qualifications
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 $65,900.00 $131, In specific locations, the pay range may vary from the range posted.
