What are the responsibilities and job description for the Regulatory Affairs Associate position at Intellectt Inc?
Job Summary
We are seeking an experienced Regulatory Affairs Associate to support regulatory submissions, labeling updates, and compliance activities for medical device products. The ideal candidate will have strong experience in regulatory affairs within a regulated medical device environment, with specific expertise in Class III implantable devices and PMA supplement submissions.
Key Responsibilities
- Prepare, author, review, and submit regulatory filings to government agencies for products requiring approval.
- Manage and execute regulatory labeling changes, including addendum labeling and supplemental labeling updates.
- Author and submit PMA supplements, including:
- 30-Day Notices
- Real-Time Reviews
- 180-Day Supplements
- Annual Reports
- Review and approve engineering study protocols and reports.
- Review and approve validation study protocols and reports.
- Assess and approve manufacturing changes for Class III implantable medical devices.
- Ensure compliance with FDA regulations, PMA guidance documents, and applicable CFR requirements.
- Collaborate with cross-functional teams including Quality, R&D, Manufacturing, and Clinical Affairs.
- Provide regulatory guidance to internal stakeholders and support audit readiness activities.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field.
- Minimum 5 years of Regulatory Affairs experience in the medical device industry.
- Hands-on experience with regulatory labeling and execution of labeling changes.
- Proven experience with Class III implantable medical devices.
- Successful track record of authoring, submitting, and obtaining approval for PMA supplements.
- Strong knowledge of FDA PMA processes, guidance documents, and CFR regulations.
- Familiarity with medical device quality systems and change control processes.
- Excellent communication, documentation, and organizational skills.
Preferred Skills
- Ability to work independently with minimal supervision.
- Strong analytical and problem-solving abilities.
- Experience leading projects or mentoring junior team members.
- Ability to manage multiple priorities in a fast-paced environment.