Regulatory Affairs Associate
Posted on: January 16, 2022
Description:Currently our client in a hybrid in/out of office
pending regulations. This person needs to be on site to begin with
to train and meet everyone. Open to remote for the right candidate
that lives somewhere out of commuting radius but doesnt want to
hire someone who straight up ask for remote. Candidate needs
flexibility for overtime. Needs someone asap but isnt going to just
take someone to get someone through the door. Their job description
is below.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
- post-market submissions i.e. PMA supplements, annual reports,
PAS reports, updating Technical Documentation, and international
- Support moreseniorRA 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 moreseniorRA 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.Skills:regulatory affairs, regulatory
submissionAdditional Skills & Qualifications:
- 2+ years of medical device Regulatory, Quality or Clinical
- 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
- Understanding of EU regulations.
- Excellent written and oral communication, technical writing and
- Strong organizational skills and time management skills.
- Ability to multitask, support multiple projects, prioritize,
conduct team meetings, and meet project deadlines. 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. Were
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.
Keywords: Aerotek, Germantown , Regulatory Affairs Associate, Other , Germantown, Maryland
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