Sr Regulatory Affairs Associate
Sr Regulatory Affairs Associate
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Maintains current and indepth knowledge of FDA and Regulatory Authority programs policies and other critical regulatory information
- Serves as a subject matter expert on various regulations and coordinates regulatory issue resolution using internal resources regulatory agencies and outside consultants as needed
- Provides guidance to assure that all regulatory submissions are planned communicated and executed per regulatory and business requirements
- Assists in the development of regulatory strategies and filings for product approvals
- Provides regulatory support to crossfunctional project teams in conjunction with direct manager
- Assists and/or prepares and submits Technical Files
- Assists and/or prepares and submits FDA submissions (e.g. PMAs 510(k)s progress reports device listings)
- Reviews and approves change requests and Change Orders
- Assures that all submission documentation record keeping and reporting meet inspection standards as established by regulatory agencies worldwide
- Makes decisions involving worldwide submissions and provide advice and counsel to other team members with the assistance of direct manager
- Participates in crossfunctional team meetings
- Minimum of 8 years of medical device regulatory affairs experience in a similar or equivalent role preferably in neuromodulation
- Bachelors degree in engineering science or related disciplines; Masters degree preferred
- Ability to develop and maintain excellent working relationships with regulatory agencies/bodies
- Knowledge of U.S. medical device regulations
Required Experience:
Senior IC
Employment Type
Full Time
