Actalent Regulatory Affairs Associate in Boston, Massachusetts
FULLY REMOTE - MUST HAVE 510K SUBMISSION WRITING EXPERIENCE
The Regulatory Affairs Scientist will provide regulatory support to the Regulatory Sciences Department ensuring compliance with applicable US and international regulations in which the company does business. Support activities include preparing product submission documentation for US and international markets and evaluating product changes for effects on regulatory license registrations.
Duties And Responsibilities Include, But Are Not Limited To
post-market submissions i.e. PMA supplements, annual reports, PAS reports, updating Technical Documentation, and international registrations.
Support more senior RA Specialists in the preparation of regulatory filings for new products, as well as post market changes and line extensions.
Review of technical documents, test protocols and reports.
Support more senior RA specialists in the review of change orders impacting design, process, suppliers, and QMS.
Developing regulatory tactics for submissions and registrations and responses to regulatory agency questions.
Developing working knowledge of US, EU, International, and Quality System regulatory requirements.
Following Quality System procedures to ensure compliance with US CFR, ISO 13485, MDR, and all other applicable regulations.
regulatory affairs, regulatory submission
Additional Skills & Qualifications:
2+ years of medical device Regulatory, Quality or Clinical experience.
B.S. degree or higher in a physical science, engineering or Regulatory Affairs. M.S. strongly preferred.
Knowledge of IDE, PMA, 510(k) and other regulatory submissions strongly preferred.
Understanding of EU regulations.
Excellent written and oral communication, technical writing and editing skills.
Strong organizational skills and time management skills.
Ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.
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.
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