The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
GENERAL SUMMARY: The Regulatory Affairs Specialist will execute and manage technical and scientific regulatory activities by assisting to identify sources for obtaining data as required for a wide range of Regulatory activities ranging from OUS registration of products to building Technical Files or 510K submissions for appropriate regulatory agency.
Prepare documentation needed for submission of 510Ks with FDA.
Determine and communicate submission and approval requirements to other team members.
Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
Monitor impact of changing regulations on submission strategies.
Monitor impact of changing regulations on OUS registration strategies and requirements.
Compile, prepare, review and submit regulatory submission drafts for team.
Maintain annual licenses, registrations, listings and patent information.
Provide regulatory input for product recalls and recall communications.
Performs other duties as assigned.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. (The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. )
Understanding of regulations and guidelines governing all phases of Medical Device development with significant guidance and supervision.
Understanding of new product development requirements and processes with supervision.
Excellent verbal and written communication skills including presentation skills.
Time management and project management skills are essential.
Required Education and/or Experience:Requires a Bachelors degree. 1 to 3 years of experience in regulatory of medical devices required (orthopedics strongly preferred). Working knowledge of US FDA and EU MDD/MDR.
Experience writing technical files and 510k submissions
Change Control Management
Implementation of Process Improvements
Telecommuting is allowed.
Additional Salary Information: Bonus - up to 4% of base salary
Benefits - Medical/Optical/Dental Insurance, Life Insurance, 401k, paid holidays and unlimited vacation
Internal Number: RA-01
About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 35 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 44 countries outside the United States. For more information, please visit www.orthopediatrics.com.