What are the responsibilities and job description for the Regulatory Affairs Associate position at GForce Life Sciences?
Regulatory Affairs Associate
6 month contract
Must be able to work on a W2
On-site in Santa Clara, CA
Requirements
- Hands-on experience with regulatory labeling, including addendum labeling, supplemental labeling, and/or execution of labeling changes
- Familiarity with regulated medical device environments and quality systems
- Filing necessary applications and handling government interactions related to regulatory processes for products requiring approval
- Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports)
- Review and approval of engineering study protocols/reports and validation study protocols/reports
- Review and approval of manufacturing changes for Class III implantable medical devices
- Planning and accomplishing goals using experience and judgment
- Performing a variety of tasks and potentially leading or directing the work of others
Qualifications
- 5 years of experience in Regulatory Affairs
- Recent experience with Class III implantable medical devices
- Proven track record of authoring, submitting, and obtaining approval for Class III implantable PMA supplements
- Knowledge of FDA PMA guidance documents and CFR regulations
- Ability to work with a wide degree of creativity and latitude
- Typically reports to a manager or head of a unit/department