Regulatory Affairs Specialist

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 53 products 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 over 70 countries outside the United States. For more information, please visit [www.orthopediatrics.com.](https://www.orthopediatrics.com./ "https://www.orthopediatrics.com./") **GENERAL SUMMARY:** The Regulatory Affairs Specialist will act as regulatory representative on cross functional New Product Development teams. Following the Phase Gate process, the regulatory affairs specialist will work closely with each project team to develop regulatory strategies, testing requirements and other documentations to assure that regulatory submissions are prepared and cleared/approved to meet the company's product launch timelines for new and modified products. **ESSENTIAL FUNCTIONS:** • Work closely with each New Product Development team in developing the regulatory strategy for the new and modified products. • Work closely with the product managers to understand the country’s registration needs and priorities and provide regulatory input to the product managers such as registration strategies, timeline, and costs. • Work closely with engineering team on the testing requirements and support the development of verification and validation testing plan. Review engineering documentation under the design history file to ensure compliance with the standards, guidance, and regulatory requirements. • Prepare regulatory submissions such as 510(k), Letter to File, Health Canada Submission, Technical Files, etc. for new and modified devices. • Updates and maintains databases with required information and status for UDI, GUDID, licenses, approvals, renewals, and other required data to assure compliance with business and regulatory requirements. • Review and approve product, supplier, and manufacturing changes for compliance with applicable regulations and applicable procedures. Work closely with Regulatory and Clinical Affairs team members to provide regulatory change assessments for each country/region where the products are registered. • Work closely with Regulatory and Clinical Affairs team members in monitoring the impact of changing regulations of each country on submission requirements and strategies. • Assign, review, revise and approve device labeling and marketing materials to ensure continued compliance with global regulations. • Provide support in developing regulatory procedures when necessary. • Provide regulatory input for product recalls and recall communications. • Performs other duties as assigned. **SUPERVISORY RESPONSIBILITIES:** There are no direct supervisory responsibilities for this position. **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 accommodation may be made to enable individuals with disabilities to perform the essential functions. • Demonstrate a fundamental understanding of medical device terminology, anatomy, regulations, standards and technical concepts • Understanding of regulations and guidelines governing all phases of Medical Device development with guidance and supervision. • Understanding new product development requirements and processes with guidance and supervision. • Excellent technical writing and editing skills, verbal and written communication skills including pres…