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.

Position Overview

We are seeking a Medical Device Writer with strong regulatory and clinical documentation experience to support the development, submission, and maintenance of EU MDR-compliant deliverables. This position plays a critical role in ensuring the accuracy, clarity, and quality of clinical and regulatory documents, while working cross-functionally with teams including Regulatory Affairs, Clinical Affairs, Quality, R&D, and Marketing.

The ideal candidate will have hands-on experience preparing Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS) plans/reports, PMCF documentation, and Summary of Safety and Clinical Performance (SSCP). A sound understanding of EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, and relevant ISO standards is essential.

Key Responsibilities

• Author, edit, and maintain Clinical Evaluation Reports (CERs) in compliance with MEDDEV 2.7/1 Rev. 4 and EU MDR Annex XIV.
• Develop and update Post-Market Surveillance (PMS) Plans and Reports, PMCF Plans and Reports, and SSCPs.
• Collaborate with clinical and regulatory teams to gather and analyze data from literature, post-market surveillance, registries, and clinical studies.
• Review and integrate risk management, usability, biological safety, and design documentation into regulatory files.
• Support the creation and remediation of Regulatory Technical Documentation (Annex II & III) in preparation for EU MDR submissions.
• Assist in gap assessments of legacy files to ensure compliance with EU MDR requirements.
• Liaise with Notified Bodies and assist in responses to regulatory questions and audits.
• Conduct online literature searches and contribute to systematic literature reviews, as applicable.
• Prepare other regulatory and clinical documents if needed including:
• Clinical study protocols and amendments
• Clinical study reports (CSRs)
• Clinical development plans
• Ensure all writing complies with ICH-E3, internal SOPs, and company templates.
• Stay current with regulatory guidance, standards, and best practices relevant to medical device documentation.
• Perform other related duties as required; limited travel may be needed (up to 25%).

Required Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related scientific field.
• 1–2 years of relevant experience in medical writing for medical devices, with a focus on EU MDR documentation.
• Proficiency in regulatory requirements including EU MDR, MEDDEV 2.7/1 Rev. 4, ISO 13485, ISO 14155, and ISO 14971.
• Demonstrated experience in drafting and managing CERs, PMS, PMCF, and SSCP documentation.
• Excellent written and verbal communication skills.
• Advanced skills in Microsoft Office (Word, Excel, PowerPoint).
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.
• Ability to interpret and present clinical data effectively.
• Familiarity with AMA style, and regulatory writing standards.
• Self-motivated with the ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications

• Experience working with Notified Bodies and supporting EU MDR audits.
• Knowledge of global regulatory frameworks (e.g., FDA 21 CFR, UK MDR, EUMDR, UKCA, Health Canada).
• Experience with systematic literature reviews or relevant software tools (e.g., DistillerSR, EndNote).
• Familiarity with orthopedic or implantable devices is a plus.
• RAPS Certification (RAC) is an asset.

LANGUAGE SKILLS: Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence. Ability to communicate effectively with customers, vendors, and other employees of the organization through written and oral communication.

MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent.

REASONING ABILITY: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Ability to extrapolate design intent and functionality from the Project Lead when direct input is not provided or available.

CERTIFICATES, LICENSES, REGISTRATIONS: Requires a valid driver’s license.

OTHER SKILLS AND ABILITIES: Requires the ability to operate a variety of standard office equipment, such as a computer, calculator, fax, photocopier, scanner, telephone, cell phone, etc. Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.

PHYSICAL DEMANDS: (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.)

While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is occasionally required to climb stairs, talk and hear. The employee is occasionally required to stand; walk; reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.

WORK ENVIRONMENT: (The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

The noise level in the work environment is that found in a “normal office environment”; noise levels during visits to other locations in the building may be moderate and occasionally loud. The employee occasionally performs work related to travel. At times this individual may be exposed to Surgical Operating Room environments.

The above statements reflect the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.