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Regulatory Affairs Specialist
This is a 12 Month contract assignment
Location: San Jose California
Benefits: ACA compliant offering available
1. Collaborates and executes regulatory strategies for global registrations (including integrated RA operating plan, and use of eGPS database) and compliance activities of moderate complexity.
2. Coordinates and supports the preparation of moderately complex regulatory submissions required for worldwide registration of products outside the U.S. and EU.
3. 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.
4. 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.
5. Prepares and submits FDA establishment registrations and device listings. Obtains CFGs. Updates Master Product Files. Submits FDA laser reports.
6. 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.
7. 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.
8. Assists in implementing department procedures and maintaining regulatory requirements matrices.
9. 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.
1. Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving
2. Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
3. Ability to identify areas of concern in moderately complex projects and manage changes
4. Demonstrated organizational and planning skills, including process savvy, action oriented, focused urgency and driving for results
5. Excellent team skills with ability to influence others
6. 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
7. Computer literacy (SAP, eGPS, iRAOP, Microsoft Word / Excel / PowerPoint)
8. Detail oriented, with emphasis on accuracy and completeness
9. 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
Education and Experience:
1. B.A. or B.S. degree in health science or life science field (biology, microbiology, chemistry, engineering, medical technology, etc.), or B.A. or B.S. degree other related discipline with significant coursework in biology and chemistry. RAC Certification encouraged.
2. A minimum of 2 years’ experience working in an FDA or ISO regulated environment.
3. At least 1 - 2 years’ experience with international subsidiaries on regulatory affair is highly desirable.
4. SAP experience is preferred.
To Apply for immediate consideration please send resume to Michael Estaris at Michael.Estaris@onboardusa.com and reference job # 18-03200 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).
**Candidates must complete background and drug screenings before starting any assignment.
On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without reg.
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