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Regulatory Affairs Specialist II

Abbott Laboratories

This is a Contract position in Austin, TX posted October 9, 2021.

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 109,000 colleagues serve people in more than 160 countries.

Regulatory Affairs Specialist II – Pleasanton, CA ABOUT ABBOTT Leading an active lifestyle is important to the many people we serve.

In Abbott’s ELECTROPHYSIOLOGY & HEART FAILURE division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in EP/HF, allowing people to restore their health and get on with their lives.

WHAT YOU’LL DO We are recruiting for a Regulatory Affairs Specialist II to join our team in the Pleasanton, CA location.

In this role, you will provide support for the regulatory department to ensure efficient and compliant business processes and environment.

You will play a consultative role by partnering across business functions assisting in identifying data needed, obtaining required documentation, and ensuring that submissions are effectively presented for the registration of products worldwide.

You may be preparing and/or submitting documentation needed for worldwide registration.

Responsibilities: Develops international strategies for regulatory approval of company products.

Coordinates, compiles and submits international regulatory submissions, including filing and/or creation of Dossiers, Premarket Notifications, Supplements, Change Notifications, and other country-specific product registrations.

Prepares robust regulatory applications to achieve departmental and organizational objectives.

Represents RA on cross-functional product development and manufacturing support teams.

Guide teams to provide content for International submissions, participates in design reviews as needed.

Acts as liaison between the Company and in-country affiliates/the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.

Maintains ongoing surveillance and analysis of all pertinent 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.

Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.

Interfaces directly with regulatory agencies as needed.

Conducts reviews of product and manufacturing changes for compliance with applicable regulations.

Communicates with and maintain productive, constructive relationships with external customers as required – regulatory authorities, notified-bodies, in-country affiliates and/or distributors.

Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Complies with 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.

EDUCATION AND EXPERIENCE YOU’LL BRING Required Bachelor’s degree in a technical discipline 3 years of related regulatory submission experience from a medical device and/or pharmaceutical industry Familiar with relevant US/international regulatory requirements for medical devices including Quality Systems standards and clinical investigations Proficient with MS Office suite (Word, Excel, Outlook) Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Preferred Advanced level degree Experience with international medical device regulations (in APAC, ANZ, LA, EMEA, etc.) and submissions Previous experience working in a highly matrixed and geographically diverse business environment WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.

We offer: Training and career development , with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

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

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