Principal International Regulatory Product Specialist - 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 Principal International Regulatory Operations Specialist 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.

As an individual contributor, the Principal Specialist will 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. This new team member assists in identifying emerging regulations, interpreting them and ensuring that they are effectively presented to different stakeholders across the organization. Additionally, may prepare and submit documentation needed for registration worldwide or oversee such preparation.

What You'll Work On

Develops worldwide strategies for regulatory approval of new and modified products.

Oversee processes and team involved with obtaining and maintaining product registration, release authorization and release of product to specified geographies.

Identify and react to emerging issues.

Assist in SOP development and review

Provide regulatory input to 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 documentation for gap assessments submitted.

Monitor impact of changing regulations on submission strategies.

Maintain annual licenses, registrations, listings and patent information.

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.

Contribute to the development and functioning of the crisis/ issue management program.

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

Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.

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

2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, engineering, scientific affairs, operations, or related area.

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

Proficient with Excel and PowerPoint and presenting information to leadership

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

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

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 $95,500.00 - $(phone number removed). In specific locations, the pay range may vary from the range posted.

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