Senior Regulatory Affairs Specialist
Company: Abbott Laboratories
Posted on: May 4, 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.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 DOThis position
performs specialized level work assignments and/or analyses,
evaluation, preparation, and submission of documentation for the
worldwide regulatory registration, ensuring products and procedures
comply with regulatory agency specifications. Supports necessary
regulatory activities required for product market entry
- Prepares robust regulatory applications/submissions and
technical file documentation (either for FDA, Notified Bodies or
for international regulatory agencies) to achieve departmental and
- Conducts reviews of product and manufacturing changes for
compliance with applicable regulations.
- Acts as a regulatory representative on core product development
teams, communicates regulatory requirements and impact of
regulations to the development team. Provides guidance and
- Reviews and evaluates communications to ensure communications
convey all necessary detail and adhere to applicable regulatory
standards including those set by the FDA, Notified Bodies or other
worldwide regulatory agencies to various international
- Maintains pertinent domestic and 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.
- Independently interacts and builds partnership with FDA and
Notified Bodies (primarily in the US and EU).
- Work with cross-functional team to support product release
- Reviews protocols and reports to support regulatory
- Support all Company initiatives as identified by management and
in support of Quality Management Systems (QMS), Environmental
Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) and
international regulations, other regulatory requirements, Company
policies, operating procedures, processes, and task
- Maintains positive and cooperative communications and
collaboration with all levels of employees, customers, contractors,
- Performs other related duties and responsibilities, on
occasion, as assigned EDUCATION & EXPERIENCE YOU'LL BRING
- BA or BS degree in a technical discipline.
- Minimum 5 years of regulatory experience with medical devices;
experience with Class III medical devices highly preferred.
- Experience with either 510(k) applications, IDEs, PMA or PMA
supplements and US device regulations and experience with EU
submission and other international medical device regulations and
submissions; EU MDR submission experience highly preferred.
- Must be familiar with regulatory requirement for medical
devices in the US and EU (at a minimum) including Quality Systems
and ISO standards.
- Strong verbal and written communication skills with the ability
to effectively communicate at multiple levels in the
- Ability to identify and solve problems and work independently
with little oversight.
- Experience working in a broader enterprise/cross-division
business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse
- Ability to work within a team and as an individual contributor
in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish
- Multitasks, prioritizes and meets deadlines in timely
- Strong organizational and follow-up skills, as well as
attention to detail.
- Ability to travel approximately 5%, including
- Ability to maintain regular and predictable attendance. 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
Keywords: Abbott Laboratories, Pleasanton , Senior Regulatory Affairs Specialist, Other , Pleasanton, California
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