Regulatory Specialist

Ximedica is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, Minneapolis, San Francisco, Silicon Valley, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.

We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations.  We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.  Opportunities are currently available in our Providence, RI Office.

The Regulatory Specialist provides input, active service and, as needed, leadership to our research and product development teams engaged in the design of complex medical products.

Nature of Role: The Regulatory Specialist reports to the Director of Regulatory and Clinical Affairs. This position will perform the day-to-day regulatory and human research activities for assigned projects, including participation as the regulatory and/or clinical research representative on core teams. Performing regulatory due diligence, formulating successful product approval strategies, preparing submission content and advising development teams are the core regulatory responsibilities. Additionally, acting as the regulatory and human research protection expert, as well as working hand-in-hand with other members of a research team, are the core human research responsibilities of this position.

Responsibilities:

• Will provide regulatory and human research guidance to cross-functional development team(s) in approach to submission and compliance strategies.

• Will assist in the development and implementation of regulatory and human research policies and procedures.

• Will conduct regulatory due diligence activities, analyze regulatory requirements and formulate strategies for successful regulatory approvals.

• Will advise, contribute to and prepare submissions to regulatory authorities in timely fashion, e.g. human research protocols, applications for pre-submission review, applications for product clearance/approval, technical file review submissions, etc., within defined schedules and at or above established standards.

• Will plan and coordinate the review and compilation of human research and regulatory submissions.

• Will provide regulatory advisory and contributing team member services for assigned human research projects, ensuring compliance with GMP/GCP, as required. Studies typically have moderate to high complexity in terms of design, location, data management, analysis and reporting, etc.

• Will guide conformance with applicable regulations in product development, support of claims/indications, and content labeling.

• Will follow established SOPs, QSR, GCP and other applicable regulatory requirements in the execution of all activities.

• Will proactively identify and resolve project issues and participate in process improvement initiatives as required.

Requirements:

• B.S./B.A. or advanced degree in scientific/life-sciences or related field with 4+ years of applicable industry experience and direct experience on product-related human research and regulatory affairs with particular focus on U.S. and EU market areas.

• Extensive and thorough knowledge of regulations/guidelines governing research and development of medical devices and combination products in the U.S. and the EU. Knowledge of regulatory requirements in other major markets is desirable.

• Direct responsibility for product-related human research and regulatory submissions, including successful interface/negotiations with regulatory authorities. Expertise in development, review, and approval of labeling and promotional material. Experience with in vitro diagnostic products is a plus.

• Experience in preparation, and submission of US Regulatory files (510(k)s, PMAs) as well as European technical files, design dossiers, and master files is preferred.

• Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategy plans.

• Experience with clinical research (protocol writing, IRB submissions) is desirable.

EQUAL OPPORTUNITY EMPLOYER

It is the policy of Ximedica to provide equal employment opportunities to all qualified applicants and employees regardless of race, color, religion, gender, age, national origin, sexual orientation, veteran status, disability that can be reasonably accommodated, or any other basis prohibited by federal, state, or local law.

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