Regulatory Affairs Specialist
The Regulatory Affairs Process Specialist will work with the TrackWise Regulatory Submission Tracking software database to update information and create new work flows. They will work with IT to build new work flow structures, define Work Instructions, and train the team on the TrackWie processes.
- Generate regulatory reports from TrackWise to communicate worldwide registration activities
- Establish and review Regulatory Submission Tracking procedures and work instructions
- Interact with Regulatory team leaders and peers document regulatory submissions and ongoing activities
- Interact with departments to generate reports and KPI (Key Performance Indicators)
- Maintain a "focused urgency" as required by specific events
- Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
- Assess potential impact and/or applicability to other related areas
- Assess corrective action to assure it prevents recurrence
- Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions
- Provide regulatory process training to cross-functional groups
Bachelor’s degree in a Life Science or related field with 2+ years of direct experience in regulatory within an IVD or medical device manufacturing site. Or, master's degree in field with 0-2 years of related work experience.
1-2 years of direct related experience in regulatory within an IVD or medical device manufacturing site
Sound basis of Regulatory and /or Scientific knowledge
Sound basis of process/procedure knowledge and training experience
Strong PowerPoint, Excel and Word knowledge
Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations
Able to confidently deal with ambiguous issues and provide input towards suitable actions
Strong oral and written communication and presentation skills
Effective communicator of technical & non-technical information
Ability to work in a self-directed manner to see issues through to completion
Sales Force and TrackWise experience is highly preferred
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.