Regulatory Affairs Manager - Digital Health Technologies - Diabetes Care (on-site)

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Job 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. 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 student debt program and 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 Opportunity

This Regulatory Affairs Manager - Digital Health Technology will work on-site at 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.

This Regulatory Affairs Manager - Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment.

This position has responsibility for the preparation and submission of product approval applications. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Ensures employee compliance with such policies, practices and procedures and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements.

What You'll Work On

Provides guidance on regulatory requirements and strategies to software product development project teams.

Sets strategy and directs preparation of submissions for products to regulatory agencies, to obtain timely approval to produce and market new digital products or release software features.

Creates, reviews and approves engineering changes.

Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders.

Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.

Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.

Performs related functions and responsibilities, on occasion, as assigned.

Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

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.

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 and communicate submission and approval requirements.

Participate in risk benefit analysis for regulatory compliance.

Monitor impact of changing regulations on submission strategies.

Required Qualifications

Bachelor's degree or an equivalent combination of education and work experience

Minimum 8 years' experience in the medical device industry, with 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k for Class I, II, and III medical devices.

Ability to work effectively on project teams.

Strong organizational skills with the ability to juggle multiple and competing priorities.

Scientific writing experience is required.

Working knowledge of QSR, ISO, and EN standards.

Strong working knowledge of regulatory requirements for European community, Japan, Canada, and other countries.

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

Preferred Qualifications

Bachelor's degree in medical, science or engineering related discipline.

Advanced level degree

Experience with EU and other international medical device / drugs / pharma regulations and submissions.

Experience with design controls in medical devices, IVDR, Pharma industries

Experience with Software Development Lifecycle process, IEC 62304, TIR 45 etc.

Proficient with Excel and PowerPoint and presenting information to leadership

Previous experience working in a highly matrixed and geographically diverse business environment

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

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.

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The base pay for this position is $(phone number removed) - $(phone number removed). In specific locations, the pay range may vary from the range posted.

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