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        Job Posting

Regulatory Affairs Specialist
R&D Technical Services
111 Deerwood Rd, #115
San Ramon, CA 94583

Description:  This is a Perm position in San Leandro. Job Description Position Title: Regulatory Affairs Specialist Department: Quality Assurance Reports To: VP of Quality Assurance and Regulatory Affairs We are seeking a Quality Assurance and Regulatory Affairs Specialist with experience managing the development of medical devices through the approval process. The ideal candidate will have a strong regulatory knowledge throughout product lifecycle with aspects of effective management and strategy. This position supports the RA function by assisting with the coordination and preparation of global regulatory premarket submissions. Responsibilities • Author or revise Standard Operating Procedure (SOPs) to improve regulatory compliance of the quality management system. • Work closely with R&D through product development process and design control • Author design validation documents. • Prepare, review, and approve risk management files • Assist with environmental regulations and standards (i.e. RoHS, Weee Directive, REACH, etc.) • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. • Assist the organization and preparation of regulatory submissions and all applicable documentation. • Coordinate, investigate, and analyze product complaints and make recommendations regarding their reportability • Monitor post-production events and reporting of adverse events • Participate in internal or external audits • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance • Interpret domestic or international laws, guidelines, standards, regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Directive (MDD), Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope. • Review and/or approve product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. • All other duties as requested by his/her manager.  

Requirements:  Knowledge/Educational Requirements • 3 to 5 years of Class II medical device quality or regulatory experience is required. • Bachelor’s degree preferably in a scientific discipline such as Science, or Engineering or equivalent experience. Regulatory Affairs Certification (RAC) is a plus. • Strong regulatory writing skills • Ability to apply business and Regulatory Affairs ethical standards • Excellent analytical and critical thinking skills • Able to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility testing, sterilization • Strong verbal and written communication skills, including a proven ability to translate technical documentation into effective quality documentation and regulatory submissions • Strong understanding of FDA and EU regulatory process • Good interpersonal skills and able to work well with cross-functional teams • Must be authorized to work in the US  

Salary:  $80,000.00 to $90,000.00 Annually 

Special Instructions:  Please email resume to: tammy@rdtechjobs.com 

Contact:  Tammy Vincent

 

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