Regulatory Affairs Specialist
Company: Abbott Laboratories
Location: Santa Clara
Posted on: November 22, 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.Abbott Vascular provides
innovative, minimally invasive and cost-effective products for
treatment of vascular disease. Our extensive portfolio includes
drug-eluting stents, bare metal stents, guide wires, balloon
dilatation catheters, imaging catheters and software, vessel
closure devices and peripheral stents. Our Santa Clara, CA location
is currently seeking a Regulatory Affairs Specialist. -The
Regulatory Affairs Specialist is to provide support for the
regulatory department to ensure efficient and compliant business
processes and environment. - The individual may execute tasks and
exercise influence generally at the middle management level. - The
individual may assist in the registration of products by preparing
and submitting documentation needed for registration worldwide.
WHAT YOU'LL DO
- Provide regulatory input to product lifecycle planning. Assist
in SOP development and review.
- Assist in the development of regional regulatory strategy and
update strategy based upon regulatory changes.
- Understand and investigate regulatory history/background of
class, disease/ therapeutic/diagnostic context in order to assess
regulatory implications for approval.
- Determine trade issues to anticipate regulatory obstacles.
Participate in risk benefit analysis for regulatory
- Determine and communicate submission and approval requirements.
Monitor applications under regulatory review.
- Evaluate proposed preclinical, clinical and manufacturing
changes for regulatory filing strategies.
- Assist in preparation and review of regulatory submission to
- Maintain annual licenses, registrations, listings and patent
- Assist compliance with product postmarket approval
requirements. Assist in the review of advertising and promotional
- Assess external communications relative to regulations. Review
regulatory aspects of contracts.
- Assist with label development and review for compliance before
- Submit and review change controls to determine the level of
change and consequent submission requirements.
- Contribute to the development and functioning of the crisis/
issue management program. Ensure product safety issues and product
associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall
- Individual may provide limited work direction and guidance to
peers and/or skilled non-exempt levels of employees. Participates
in the development of less experienced staff by setting an example,
providing guidance, and offering counsel. Plans and organizes
non-routine tasks w/approval. Initiates or maintains work schedule.
Establishes priorities of work assignments. May lead a departmental
- Establishes and cultivates an extensive network of support to
facilitate completion of assignments.
- Participates in determining goals and objectives for
- Influences middle management on technical or business
- May interact with vendors.
- Exercises judgment in selecting innovative, practical methods
to achieve problem resolution. Failure to obtain results or
erroneous decisions or recommendations would typically result in
serious delays and considerable expenditure of resources. EDUCATION
AND EXPERIENCE YOU'LL BRINGRequired
- Bachelor's Degree
- Minimum 2+ years experience Preferred
- Bachelor's Degree in science (biology, chemistry, microbiology,
immunology, medical technology, pharmacy,) Math, engineering, or
medical fields is preferred.
- Experience with Medical Devices containing Electrical or
Software is preferred.
- This position does not require previous regulatory experience.
2-3 years experience in a regulated industry (e.g., medical
products, nutritionals). Regulatory area is preferred but may
consider quality assurance, research and development/support,
scientific affairs, operations, or related area.
- Experience with Regulatory history, guidelines, policies,
standards, practices, requirements and precedents; Regulatory
agency structure, processes and key personnel; - Principles and
requirements of applicable product laws; - Submission/registration
types and requirements; - GxPs (GCPs, GLPs, GMPs); - Principles and
requirements of promotion, advertising and labeling; - Domestic and
international regulatory guidelines, policies and regulations; -
Ethical guidelines of the regulatory profession, clinical research
and regulatory process.
- Communicate effectively verbally and in writing. - Communicate
with diverse audiences and personnel. - Write and edit technical
- Work with cross-functional teams. - Work with people from
various disciplines and cultures.
- Write and edit technical documents. -
- Negotiate internally. -
- Pay strong attention to detail.
- Manage projects. Create project plans and timelines.
- Think analytically and critically.
- Organize and track complex information.
- Exercise judgment within generally defined practices and
policies in selecting methods and techniques for obtaining
- Has a sound knowledge of a variety of alternatives and their
impact on the business.
- Apply business and regulatory ethical standards
- Certification is a plus (such as RAC from the Regulatory
Affairs Professionals Society.) - - 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.Connect with
us at , on Facebook at and on Twitter @AbbottNews and
Keywords: Abbott Laboratories, Santa Clara , Regulatory Affairs Specialist, Other , Santa Clara, California
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