What are the responsibilities and job description for the Regulatory Affairs Associate position at Mindlane?
Position Details:
Role: Regulatory Affairs Associate
Location: Santa Clara, CA
Duration: 12 months
DUTIES & RESPONSIBILITIES:
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Author and submit PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
- Review and approve engineering study protocols/reports and validation study protocols/reports.
- Review and approve manufacturing changes for Class III implantable medical devices.
- Relies on extensive experience and judgment to plan and accomplish regulatory goals.
- May lead and direct the work of others, providing guidance and support on regulatory matters.
- Maintain compliance with FDA PMA guidance documents and CFR regulations.
EXPERIENCE AND EDUCATION:
- 5-8 years of direct experience in regulatory affairs, with recent experience specifically related to Class III implantable medical devices.
- Proven successful track record of authoring, submitting, and receiving approval for Class III implantable PMA supplements.
- Extensive knowledge of FDA PMA guidance documents and CFR regulations.
- May require an advanced degree in a relevant field.
- Ability to work independently and demonstrate creativity and latitude in handling regulatory challenges.
Looking forward to connecting and discussing how your experience aligns with this role. Please feel free to reach out at your earliest convenience.
