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Regulatory Affairs Specialist

Abbott

This is a Contract position in Winston-Salem, NC posted May 24, 2022.

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 113,000 colleagues serve people in more than 160 countries.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives.

Thats why were 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.

Were revolutionizing the way people monitor their glucose levels with our new sensing technology.

Our location in Alameda, CA currently has an opportunity for a Regulatory Affairs Specialist that is focused on exciting and ground-breaking work with Commercial teams on advertising & promotional review (ad promo).

WHAT YOU’LL DO As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the regulatory department to ensure efficient and compliant business processes and environment.

The individual may execute tasks and partner across business functions.

The individual will be reviewing Ad Promo materials and identifying data needed, obtaining data and ensuring that they are effectively presented to substantiate claims.

The individual will also have opportunities to participate in worldwide regulatory submissions.

This is a broad scoped position with strong opportunity for growth and career development in the following areas: Review promotional and advertising materials working with marketing to provide regulatory compliance input.

Assist with label development and review for compliance before release.

Assist in SOP development and review.

Experience with submission for NPI and on market products (510K, PMA and Health Canada submissions).

Provide regulatory input to product lifecycle planning.

Assist in the development of regional regulatory strategy.

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.

Compile, prepare, review and submit regulatory submission to authorities.

Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

Assist compliance with product post marketing approval requirements.

EDUCATION AND EXPERIENCE YOU’LL BRING: Bachelors degree is required (or) equivalent with 2 to 4 years of regulatory affairs experience within medical devices is preferred.

Experience with review of labeling, promotional, and or advertising materials is desired.

WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.

We offer: A fast-paced work environment where your contribution is essential to success 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: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) 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.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter AbbottNews and AbbottGlobal.

An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjatabbott.com