Regulatory Compliance Specialist/Sr Specialist/Staff Specialist
- Job type: Permanent
- Salary: competitive
- Location: San Jose
- Reference: RE-32506999
My client is a blue chip medical device company located in the South Bay Area and is looking to bring on a new member to their regulatory compliance team. This position can be flexible from a more entry level type position all the way up through senior staff level for the appropriate individual. This person would focus on all post market regulatory responsibilities for their given product line within the larger organization.
* Responsible for developing, applying, and revising procedures to maintain and improve quality compliance and standards as well as reviewing and approving concessions, non-conforming product and corrective actions as denoted by applicable regulations and procedures
* Use understanding of industry practice and company policies to effectively implement and improve product quality and the quality management system
* Responsible for completing and approving investigations, and, determining reportability to the appropriate regulatory agencies for events that either contributed or could have contributed to adverse events
* Review reports of customer complaints and assess them for regulatory reporting
* Submit initial and follow-up reports to device related regulatory agencies as appropriate
* Interact with regulatory agencies on adverse event reporting and vigilance reports
* Review and approve non-conformances and planned deviations
* May coordinate recalls and complete associated documentation
* Recommend corrective and/or preventive actions to address non-conformities and deviations
* Work with engineering groups to ensure testing as required on product investigations is completed
* Interact with customers and sales force to solve reliability issues and/or complaint issues.
* Aid in developing and executing process and product protocols and reports
* Aid in developing statistical process controls and analyzing data
* Provide leadership, training and mentorship to team members
* May aid in developing and executing process and product protocols and reports
* May participate in internal and external audits
* Engineering schematics/drawing/prints reading and interpretation
* Excellent organizational, problem-solving, and analytical skills to lead to sound, timely decisions
* Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
* Proficient with Microsoft Office and ability to learn corporate systems.
* Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
* Bachelors degree (life sciences or engineering preferred) years of experience dependent on level, 0-2 for entry level, 3-5 mid, 5+ senior/staff
* Previous experience in regulated industry
* Knowledge of applicable international regulations and standards preferred (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.)
* Regulatory Affairs Certification desired.