Sr Regulatory Affairs Specialist (Pacific Time Zone Remote Optional)
Company: Becton Dickinson
Location: San Diego
Posted on: June 25, 2022
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Job Description:
Responsibilities Job Description Summary Job Description Be part
of something bigger BD is one of the largest global medical
technology companies in the world and is advancing the world of
health by improving medical discovery, diagnostics and the delivery
of care. We have over 65,000 employees and a presence in virtually
every country around the world to address some of the most
challenging global health issues. The Sr. Regulatory Affairs
Specialist is responsible for support of a variety of regulatory
activities and projects with oversight from senior regulatory
staff. The focus is on representing RA in new product development
core team(s), creating and executing regulatory strategy, change
assessment, and completing high quality US and EU regulatory
submissions per project plans. Activities include but are not
limited to the following: Represents RA in new product development
team(s). Responsible for completion of regulatory strategy, review
and approval of design control related documents. For changes to
products and processes, conducts regulatory assessments, authors
and maintains Letters to File, and tech files updates. Writes and
leads the completion of high quality 510(k)s and/or EU Technical
Documentation (both IVDD and IVDR) with limited supervision.
Obtains FDA clearance of 510(k)s, and Notified Body's approval of
Technical Documentation, with desired claims, per project plan.
Works will entail problems of moderate complexity and diverse
scope, including data analysis and ownership of task execution and
completion. Assists in implementing department procedures and
maintaining regulatory requirements. Provides support to Sr. RA
manager, and performs other related duties and assignments as
required. Minimum Qualifications: Typically requires 3 years of
U.S. 510(k) and EU Technical Documentation experience for IVD
instruments, software, and/or reagents required. Familiar and or
experience with regulatory requirements for IVD manufacturers such
as design control requirements, listings, establishment
registrations, etc. Excellent project management, negotiation,
communication (written and verbal) and interpersonal skills;
ability to communicate and work in a diverse team environment;
effective interactions with technical personnel (scientific and
legal). Excellent team skills with ability to influence others
without authority. Ability to exercise independent judgment and
discretion within a broadly defined range of policies and
practices.This includes analytical problem solving. Ability to
handle multiple tasks and to prioritize and schedule work to meet
business needs. Ability to identify areas of concern in moderately
complex projects and manage changes. Demonstrated organizational
and planning skills, including process savvy, action oriented,
focused urgency and driving for results. Ability to write high
quality submission documentation. Computer literacy (SAP, Microsoft
Word / Excel / PowerPoint). Detail oriented, with emphasis on
accuracy and completeness. Education and Experience: B.S. degree in
health science or life science field (biomedical engineering,
engineering, computer science, biology, medical technology, etc.).
RAC Certification a plus. Typically requires a minimum of3 years'
experience working in an U.S. FDA/or ISO regulated environment and
medical device industry. EU IVDR experience a plus. Flow cytometer
experience a plus. Location: The ideal candidate will be located in
the Bay area; however, we are also open to considering candidates
that are willing to work remotely supporting the Pacific Time Zone.
For many roles at BD, employment is contingent upon the Company's
receipt of sufficient proof that you are fully vaccinated against
COVID-19. In some locations, weekly testing for COVID-19 may be
available instead of vaccination. Consistent with BD's Workplace
Accommodations Policy, requests for accommodation will be
considered pursuant to applicable law. Why join us? A career at BD
means being part of a team that values your opinions and
contributions and that empowers you to bring your authentic self to
work. Here our associates can fulfill their life's purpose through
the work that they do every day. You will learn and work alongside
inspirational leaders and colleagues who are equally passionate and
committed to fostering an inclusive, growth-centered, and rewarding
culture. Our Total Rewards program - which includes competitive
pay, benefits, continuous learning, recognition, career growth, and
life balance components - is designed to support the varying needs
of our diverse and global associates. To learn more about BD visit
https://jobs.bd.com/ Becton, Dickinson and Company is an Equal
Opportunity/Affirmative Action Employer. We do not unlawfully
discriminate on the basis of race, color, religion, age, sex,
creed, national origin, ancestry, citizenship status, marital or
domestic or civil union status, familial status, affectional or
sexual orientation, gender identity or expression, genetics,
disability, military eligibility or veteran status, or any other
protected status. PDN Primary Work LocationUSA CA - San Jose
Additional LocationsUSA CA - San Diego (BDB) Work Shift Apply Save
Job PDN-95e258d0-a4c7-4cf4-ab9b-43991be2034f
Keywords: Becton Dickinson, San Diego , Sr Regulatory Affairs Specialist (Pacific Time Zone Remote Optional), Other , San Diego, California
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