Senior Specialistt of Regulatory Affairs

Center Valley, Pennsylvania
Job Type
US$ 19.00 - US$ 38.00 per hour, $19 - 38 per hour + none
Ref. Number
Ross, Natacha, Spherion
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Job Description

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.

- 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.

Working hours: 8a - 5p

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.
--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.

Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.

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