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Regulatory Affairs Specialist
R&D Technical Services
111 Deerwood Rd, #115
San Ramon, CA 94583
|Description: This is a Perm position in San Leandro.
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.
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.
Bachelors 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: firstname.lastname@example.org |
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