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Regulatory Affairs Specialist - Dental Devices - Dracut/Hybrid

Company: Michael Page
Location: Dracut
Posted on: November 22, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Our client is a leading dental equipment manufacturer based in the Dracut, MA area. Boasting a beautiful facility, they are looking to bring a Regulatory Affairs Specialist onto their team on a hybrid basis (between office and home).

Client Details
Our client is a leader in the development of dental equipment throughout the Northeast. Between their state of the art facility, unparalleled benefits, and beautiful facility, this is an optimum position for a Regulatory Affairs Specialist.

The successful senior regulatory affairs specialist will...
The Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and/or verbal) by owning the following tasks: Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
Advise product design teams on regulatory strategy requirements for specific new products/solutions.
Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
Identify potential regulatory approvals risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project.
Provide audit and CAPA support.
Communicate application progress to internal stakeholders.
Maintain regulatory files and tracking databases.

The qualified senior regulatory affairs specialist will have...
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
RAPS RAC preferred.
Minimum of 3 years of regulatory experience in the medical device industry (EU MDD/MDR, Health Canada, US FDA class II and class III, etc.)
Successful preparation of domestic and international medical device license requirements.
Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.

Job Offer
Work on a hybrid model, spending half of the week at home and half of the week at their brand new facility
Work directly with upper management at a position that promotes internal growth
Competitive compensation with upwards mobility experience
Apply directly and/or contact Cameron Cyker to learn more. All qualified candidates can expect feedback within 48 hours.

Keywords: Michael Page, Lowell , Regulatory Affairs Specialist - Dental Devices - Dracut/Hybrid, Healthcare , Dracut, Massachusetts

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