PDS Tech Inc Regulatory Affairs Specialist 2 in Newark, Delaware
PDS Tech is seeking a candidate for the Regulatory Affairs Specialist 2 position located in Newark, DE.
Participates in writing and filing appropriate FDA premarket submission to ensure devices are commercially available in the U.S.
Supports the review of promotional material and device labeling for regulatory compliance.
Participates in regulatory projects, project schedules, and product introduction process.
Participates in decision making on regulatory submission issues using historical knowledge, legal counsel and FDA's current regulations on medical device industry.
Prepares technical documentation for in-vitro diagnostic products to support global registrations.
Communicates with regional units to ensure understanding of registration requirements.
Works with different organizations to assemble technical documentation required.
Updates information of submission tracking for registration projects.
BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience.
Knowledge and Experience:
Experience in regulatory affairs around In-Vitro Diagnostics. Knowledge of In-Vitro Diagnostic Directives (EU) and international registrations are highly desirable.
- Communication Skills –
Verbal – conference calls, cross-functional communications, etc
Written – emails, technical reports, presentations, etc
- Computer Knowledge –
MS Office, specially Excel
Sharepoint / Teamspace
- Organized –
- Work queue – prioritizes, updates registration status.
- Technical Background –
Basic statistics (product claims)
Able to write and understand technical reports
knowledge in regulatory affairs, experience on in-vitro diagnostics, preparation of technical reports are key attributes.
Knowledge of international registration requirements is an absolute plus.
Educational background should be at least a BS in Science, Medical Technologist, Bio-chemistry or biology. Experience in field can compensate for the education.
This position may require you to submit to and pass a drug test and/or background check. If this is a hands-on position, you may also be required to pass a safety and productivity examination.
PDS Tech, Inc. will comply with all applicable federal and state laws governing the use of such background checks and drug tests.
PDS Tech, Inc. is an Equal Opportunity Employer and will not discriminate against applicants on the basis of race, color, religion, sexual orientation, gender identity, national origin, veteran status, or disability.
Founded in 1977, PDS Tech, Inc. is one of the nation's premier specialty staffing firms with 31 offices nationwide. We offer a full range of benefits including:
Immediate 401(k) eligibility
Please note availability of benefits may vary by position
PDS specializes in Engineering and IT arenas including Aerospace, Defense, Electronics, Telecommunications, Automotive, and Energy just to name a few. Our reputation, track record, and years of continuous growth reflect the commitment to quality that our employees and clients experience first-hand. To find out more about PDS, check out http://www.pdstech.com/
$$$ PDS pays for referrals! $$$
We pay thousands each month in referral bonuses!
Contact a recruiter for details
To find a recruiter near you, look at our Branch Locator. at http://www.pdstech.com/pds_locations.htm