Kelly Services Regulatory Affairs Manager - Medical Device in Lexington, Massachusetts
Kelly Services is seeking candidates for a one-year Regulatory Affairs (RA) Manager assignment in Lexington, MA. The Regulatory Affairs Manager will serve as the lead device regulatory affairs member of project development teams, primarily focused on (but not limited to) device products. The RA Manager will provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development. Specifically, supporting all device labeling activities, packaging and their regulatory content, IFU development and coordinating labeling deliverables with device QA.
Job duties include:
Develop regulatory submission strategies in agreement with defined product development objectives.
Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned device projects.
Prepare and submit device content for IND and NDA applications, or author 510K, and CE Mark regulatory filings.
Minimum of 5 years + experience in device development and registration activities, including personal management of an approved devices from initial development through to approval and market launch.
Prior project management experience a plus.
Demonstrated capability to lead and motivate staff is essential.
Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
Perks of being a Kelly employee:
Weekly electronic pay
Access to more than 3,000 online training courses though Kelly Learning center
Group rate insurance options available immediate upon hire*
Service bonus plan and holiday pay*
Online application system
Never an applicant fee
*perks to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at email@example.com.
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.