Actalent
- Hiring a Fully Remote Remote Regulatory Affairs Associate *
- Top Medical Device company
- Fully Remote but will run on PST usually within 9AM-7PM range
- 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 (Master’s in regulatory preferred) and 2-5 years of direct experience in the field.
Recent experience within 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.
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
To apply for this job please visit careers.actalentservices.com.