Kelly Services Senior Regulatory Affairs Specialist in Center Valley, Pennsylvania
Senior Regulatory Affairs Specialist, Center Valley, PA
Kelly Services is currently seeking an Senior Regulatory Affairs Specialist for one of our top clients in Center Valley, PA.
Type : Contract/Temp-to-Hire
Scope: Assist the Manager, Regulatory Affairs in obtaining approval to market OSTA medical devices in the worldwide markets served by OSTA. This position shall primarily support software product initiatives, which include a first-to-market artificial intelligence project related to colonoscopy. Critical success factors for this project lie in development and execution of the regulatory requirement and pathway strategy. This will require close partnership with key functional stakeholder internal groups like Medical Affairs and Upstream Marketing and FDA as the key external stakeholder.
Principal duties and responsibilities will include:
Represent Regulatory Affairs in product teams developing new products to define global regulatory requirements. Responsible for developing of Global Regulatory Pathway Assessment strategy document.
Review and approve product labelling (including IFU review). Work closely with Upstream Marketing and the Regulatory Compliance Team in developing labelling materials.
Develop, coordinate, prepare and maintain US medical device submissions such as Pre-Submissions, 510ks, PMAs, IDEs and applicable supplements and annual reports and liaise with FDA reviewers as needed
Develop, coordinate, prepare and maintain medical device submissions for Canadian Class 2, 3 or 4 Device License submissions. Respond to regulatory authorities’ requests for additional information.
Interface with International Regulatory Affairs Team to support preparation of dossiers for registration for other international markets such as Japan, the Far East, Australia and Latin America.
Assist with maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management.
Keep abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes. Advise regulatory management of changes and as appropriate communicate regulatory initiatives or changes to other staff.
As needed, assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
Assist with compliance activities related to FDA regulations and ISO quality system standards. May assist in the performance of internal quality and regulatory compliance audits and monitoring corrective actions.
Review product and process documentation for assigned projects to ensure compliance with change control requirements and determining whether regulatory submissions are required,
All other essential duties as directed.
Regulatory affairs experience in the Medical Device industry is mandatory [minimum 5 years with BS/BA, or 3 years with MS preferred].
BS/BA required, preferably in engineering or life sciences. RAC accreditation preferred. Post-graduate degree a plus.
Experience with software driven, and stand-alone medical device software and IEC 62304 software development lifecycle is desired.
Knowledge of latest FDA and industry guidance on artificial intelligence is a plus.
If you are interested in the position, please apply to this posting with an updated resume. Thank you for your time and I look forward to working with you.
Lauren Rogers, Kelly Services Scientific Recruiter
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
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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
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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.