Regulatory Scientific Writer
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 Scientific Writer is responsible for performing comprehensive literature reviews, and reviewing and editing promotional, training, and educational materials for compliance with corporate guidelines and applicable regulations. Responsibilities include comprehensive or ad hoc scientific literature reviews to support regulatory submissions, testing, or engineering rationales in conjunction with other Globus departments, requiring working knowledge of Globus products and their indicated uses.
The Regulatory Scientific Writer isenthusiastic, positive, even-tempered and effective in building workingrelationships with Product Development, Creative Services, MERC, QualityAssurance, and other departments within Globus. Experience should demonstrate strongwriting skills, dependability, flexibility and maturity.
The responsibilities of the position include, but are not limited to, the following:
- Reviewing and editing promotional, training, and educational materials for compliance with corporate, FDA, and international regulations and guidelines
- Performing or reviewing comprehensive literature reviews in support of US or international regulatory submissions (i.e. literature reviews for CE files, scientific literature reviews to support FDA submissions)
- Performing literature searches and analysis to support US or international regulatory submissions for testing justification, engineering rationales, expanded indications, etc.
- Reviewing product labeling for content and consistency
- Helping to develop relevant Regulatory procedures and work instructions as necessary
- Ensuring conformance to ISO, CE, FDA and other international/local regulations
- Understanding spinal and orthopedic surgical techniques and the use of Globus products
- Performing additional tasks or projects as requested by supervisor or senior management
- 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
- BS degree in health or science-related field; English or engineering degree is a plus
- Minimum of 2 years’ experience in Regulatory Affairs in medical device or health-related field
- Must enjoy reading and writing scientific and technical materials
- Must be able to perform scientific literature review on a specified topic
- Able to maintain confidentiality in dealing with regulatory matters and clinical data
- Self-starter with excellent organizational, planning, and follow-up skills
- Strong attention to detail
- Willingness to learn and a positive attitude
- Able to prioritize and handle several projects concurrently and to meet strict deadlines
- Excellent verbal and written skills
- Good communication and interpersonal skills with an ability to work effectively in a team environment and at all levels of the organization
- 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.