Regulatory Affairs Associate
Regulatory Affairs Associate
Intellectt Inc
Alameda, CA
See who Intellectt Inc has hired for this role
Role: Regulatory Affairs Associate
Location: Alameda, CA - 94502
Duration: 12 Months
Job Description
Location: Alameda, CA - 94502
Duration: 12 Months
Job Description
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
- Review/approval of engineering study protocols/reports and validation study protocols/reports.
- Review and approval of manufacturing changes for Class III implantable medical devices.
- May require an advanced degree and 5-8 years of direct experience in the field.
- Recent experience with Class III implantable medical devices;
- Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements;
- knowledge of FDA PMA guidance documents and CFR regulations.
- Relies on extensive experience and judgment to plan and accomplish goals.
- Performs a variety of tasks.
- May lead and direct the work of others.
- A wide degree of creativity and latitude is expected.
- Typically reports to a manager or head of a unit/department
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Legal -
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Intellectt Inc by 2x
See who you knowGet notified about new Regulatory Affairs Associate jobs in Alameda, CA.
Sign in to create job alertSimilar jobs
People also viewed
-
Remote Litigation Legal Assistant/Paralegal
Remote Litigation Legal Assistant/Paralegal
-
Legal Assistant
Legal Assistant
-
Legal Administrative Assistant
Legal Administrative Assistant
-
Intellectual Property Paralegal
Intellectual Property Paralegal
-
Litigation Secretary
Litigation Secretary
-
Legal Administrative Assistant
Legal Administrative Assistant
-
Litigation Paralegal
Litigation Paralegal
-
Legal Operations Associate
Legal Operations Associate
-
Corporate Legal Assistant UBRJP00026765
Corporate Legal Assistant UBRJP00026765
-
Assistant General Counsel, Contracts
Assistant General Counsel, Contracts
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More