Regulatory Affairs Specialist

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 107,000 colleagues serve people in more than 160 countries

     

JOB DESCRIPTION:

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. 

Our location in Alameda, CA currently has an opportunity for a Regulatory Affairs Specialist that is focused on exciting new product registrations and existing products maintenance from a Canada and Latin America perspective, and also working with commercial on advertising & promotional review (ad promo). This is not a remote role and we are not providing relocation assistance.

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 play a consultative role by partnering across business functions.  The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products in Canada and Latin America.  The individual may prepare and submit documentation needed for registration or may oversee such preparation. This is a broad scoped position with strong opportunity for growth and career development.

·  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.
·  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.
·  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.
·  Assist with label development and review for compliance before release.
·  Review promotional and advertising materials working with marketing to provide regulatory compliance input.

EDUCATION AND EXPERIENCE YOU'LL BRING:

Bachelor’s degree (or equivalent) with 2 to 4 years of regulatory affairs experience within medical devices in Canada and Latin America. Experience with class III PMA products or CE marked product is preferred. Diagnostics and pharmaceuticals regulatory affairs experience is considered. 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
 

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.

     

JOB FAMILY:

Advertising and Promotion

     

DIVISION:

        

LOCATION:

United States > Alameda : 1360-1380 South Loop Road

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf