BD (Becton, Dickinson and Company) International Regulatory Affairs Specialist in San Jose, California
Job Description Summary
The International Regulatory Affairs Specialist is responsible for the preparation and documentation of regulatory submissions to government agencies. She/He works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors. She/He exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments. May provide leadership by assigning work and resolving complex problems.
Primary Job Responsibilities:
Collaborates and executes regulatory strategies for global registrations (including integrated RA operating plan, and use of eGPS database) and compliance activities of moderate complexity.
Coordinates and supports the preparation of moderately complex regulatory submissions required for worldwide registration of products outside the U.S. and EU.
Participates in interactions with global regulatory agencies on premarket submission requirements, document formats, labeling claims, etc. Organizes and manages (with oversight) meetings with regulators, including development of agendas and training/preparation of company personnel attending the meetings.
Monitors worldwide laws and regulations through websites and publications, and identifies and communicates items needed for interpretation for impact to BDB regulated products. He/she will also provide comments to staff/senior RA associates for inclusion in BDX responses to regulators and other agencies.
Prepares and submits FDA establishment registrations and device listings. Obtains CFGs. Updates Master Product Files. Submits FDA laser reports.
Reviews changes to products and manufacturing locations, and performs associated Regulatory tasks including but not limited to international registrations/re-registration impact assessments and supports, ship hold, etc.
Provides a moderate level of regulatory expertise and experience to the unit/segment moderately complex programs, serving as a Core Team member and Extended Team member as assigned.
Assists in implementing department procedures and maintaining regulatory requirements matrices.
Provides support to staff / senior RA Specialists, and performs other related duties and assignments as required. Brings Regulatory Affairs questions/issues to the attention of RA management.
Education and Experience:
Minimum of a Bachelor's of Science Degree in Life Sciences
Minimum of 2 years’ experience working in a medical device environment.
Minimum of 2 years prior experience working on product regulatory submissions.
SAP experience is preferred.
Minimum knowledge and skills:
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.
Excellent team skills with ability to influence others.
Excellent interpersonal skills, ability to communicate and work in a diverse team environment; effective interactions with technical personnel (scientific and legal). This includes excellent written and verbal communication skills.
Computer literacy (SAP, eGPS, iRAOP, Microsoft Word / Excel / PowerPoint).
Detail oriented, with emphasis on accuracy and completeness.
Familiar with establishment registrations, device listings, CFGs, ship holds, FDA laser reports, Design History Files, Device History Records, QC testing, Stability reports and R&D reports.
Primary Work LocationUSA CA - San Jose
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