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Regulatory Quality Engineer

Job Description

Provides international and domestic regulatory affairs planning to the development and implementation of products and services. Coordinate and document internal regulatory processes, such as regulatory submissions, license renewals, or registrations. Responsible for compiling and preparing materials for submission to regulatory agencies (510K, PMA, De Novo, Notice of Change, Dossier, etc).

Responsibilities
* Coordinate efforts associated with the preparation of regulatory documents or submissions (510K submissions, Health Canada Device License Applications, Notified Body and EU Technical Files).
* Coordinate, prepare, or review regulatory submissions for domestic and international regulatory agencies.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
* Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
* Work closely with product development, clinical, and marketing teams to gain required information for new product submissions.
* Manage document control, including document review, approval, archiving, maintenance of document list, and working with other functional groups on development of new processes or procedures.

Qualifications:

Must:

-Have a degree in engineering (Biomedical Engineering is preferred)

-Experience working with a Quality Management System

-2+ years in Regulatory Affairs, 510k submissions or MDR reporting

-Must have strong documentation skills

-Experience within an FDA regulated environment

Plus:

-Project Management

-Experience with ISO 13485

-Experience within Medical Devices

-Clinical evaluation report experience

-Data analysis experience

-MDR Reporting background

-Complaint handling experience




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Snapshot

Employment Type Full-Time
Job Type Engineering, QA - Quality Control
Education Not Specified
Experience Not Specified
Manages Others Not Specified
Industry Medical Equipment
Required Travel Not Specified
Job ID 6869877
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Regulatory Quality Engineer


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