What are the responsibilities and job description for the Regulatory Affairs Specialist position at Intellectt Inc?
Job Title: Regulatory Affairs Associate
Location: Santa Clara, CA
Duration: 12 Months
Schedule: 8:00 AM – 5:00 PM
Job Description:
The Regulatory Affairs Associate will support regulatory strategy, submissions, and compliance activities for Class III implantable medical devices. The role requires experience with FDA regulatory pathways, PMA supplements, and labeling requirements. The candidate will work closely with cross-functional teams including engineering, quality, and manufacturing to ensure compliance throughout the product lifecycle.
Responsibilities:
- Manage regulatory labeling activities, including addendum and supplemental updates
- Review and approve engineering study protocols and reports
- Review and approve validation protocols and reports
- Assess and approve manufacturing changes for Class III implantable devices
- Ensure compliance with FDA PMA guidance documents and CFR regulations
- Act as a liaison for regulatory authority interactions, including submission handling and follow-ups
- Collaborate with cross-functional teams on product development and change management
- Provide regulatory guidance and support junior team members as needed
Required Qualifications:
- Minimum 5 years of Regulatory Affairs experience
- Experience with Class III implantable medical devices
- Strong experience in PMA supplement authoring, submission, and approvals
- Hands-on experience with regulatory labeling (addendum and supplemental changes)
- Solid understanding of FDA regulations and medical device quality systems
- Ability to manage multiple projects independently
Preferred Skills:
- Experience in a highly regulated medical device environment
- Strong analytical, documentation, and communication skills
- Ability to work independently and lead cross-functional initiatives