Regulatory Affairs Specialist

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Job description

Regulatory Affairs Specialist:

Kelly® Science & Clinical is seeking Regulatory Affairs Specialist professionals who are eager to bring the latest scientific discoveries to life in order to create a brighter, safer and healthier future for all. If you're passionate about shaping the world we live in and ready for a new challenge, this may be the perfect opportunity for you.

Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files.

Responsibilities:

• Write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
• Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, 510(k) s, medical device licenses, and CE dossiers for EU, NRTL certifications etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.
• Assist in preparing response to regulatory authority's questions within assigned timelines.
• Stay abreast of regulatory procedures and changes in regulatory climate.
• Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.
• Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
• Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
• Assist in preparing clinical trial site ethics review board applications for investigational device trials. Prepare interim or final reports for trial site ethics boards as required.
• Other duties as assigned.

Minimum Qualifications:

• Bachelor's degree in Engineering or Science or related scientific discipline, or equivalent. Higher degree/PhD will be preferred for senior level positions.
• Relevant regulated industry experience (i.e., FDA or EMA).
• Experience working at the FDA is highly preferred.
• Experience filing IND/NDA submissions (check which Phase of Clinical Development the talent has, or the client requires).
• Experience with interacting with specific Divisions within the FDA (i.e., CDER or CBER).
• Knowledgeable of FDA Clinical Trial Guidance's and regulations, pharmaceutical development process, and industry standard practices.
• Prepare scientific and regulatory documents such as study protocols, investigator brochures, informed consent forms, annual reports, IND applications, IDE applications, and summary report.
• Regulatory correspondence with PI's and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates.
• Maintain TMF related to ongoing studies and all regulatory documentation.
• Working knowledge of database management programs, analytical tools, and CTMS.

#TJP2021_SPEC

#TJP2021_SCT

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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