At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them.
Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that speed is critical because life cannot wait. Join us!
The Regulatory Writer is responsible for conducting comprehensive literature reviews and prepare clinical data summaries, and reviewing and editing promotional and educational materials for compliance with applicable regulations. In addition, the Writer will also work to manage completion of post-market surveillance reports for CE technical files or dossiers, develop regulatory submissions in conjunction with other Globus departments, learn in-depth about products under review, maintain an excellent understanding of global medical device regulations in Europe, Japan, Latin America and other geographies and relevant regulations.
The responsibilities of the position include, but are not limited to, the following:
- Conducting comprehensive literature reviews and preparing clinical data summaries in support of regulatory submissions (i.e. CERs for CE technical files and dossiers)
- Reviewing and editing marketing, promotional, and educational materials for compliance with corporate, FDA, and international regulations and guidelines
- Creating a Post Market Surveillance (PMS) schedule and coordinating the completion of PMS reports with Product Development; Reviewing PMS reports in accordance with relevant SOPs and work instructions
- Preparing and reviewing regulatory registrations and notifications, in accordance with international regulations, as requested by the Group Manager, International Regulatory
- Aiding in preparation of US or international regulatory submissions, specifically literature reviews, adverse event analysis, or other aspects as needed
- Reviewing product changes/modifications, submissions and labeling as needed for content and consistency
- Submitting documents and timely responses with international regulatory bodies, in accordance with local and international regulations
- Reviewing design changes and technical files for updates to documentation
- Developing relevant Regulatory procedures and work instructions as necessary
- Ensuring conformance to ISO, CE, FDA and other international/local regulations
- Understanding spinal surgical techniques and the use of spinal implant and instrument systems
- Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Representing the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
In order to be qualified for this role, you must possess the following
- Minimum of 4 years’ experience in the medical device industry; BS degree in health or science-related field – engineering degree is a plus
- Minimum of 2 years’ experience in Regulatory Affairs in medical device industry; Experience with spinal devices is a plus
- Knowledge of requirements in accordance with MDD, Japanese, Latin America and other relevant regulations, international standards (ISO 13485) and guidance documents (MEDDEVs)
- Able to maintain confidentiality in dealing with regulatory and clinical documentation
- Self-starter with excellent organizational, planning, and follow-up skills; Strong attention to detail
- Ability to work independently
- Able to prioritize and handle several projects concurrently and to meet strict deadlines
- Excellent verbal and written skills
- Ability to work effectively in a team environment and or independently while communicating with team members and customers at all levels of the organization
- Willingness to learn and a positive attitude
- Strong technical system skills (e.g. word processing, spreadsheets, databases, online research)
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.