Under general guidance, the Regulatory Submissions Specialist (R.S.S.) will create and assemble regulatory documents relating to the marketing and manufacture of medical devices.  This includes the determination of information required to accompany product (labeling and product insert sheets).  The R.S.S. will be responsible for regulatory documentation such as 510(k) submissions, regulatory and quality systems documentation requests from international distributors to support regulatory submissions and Notified Body submissions such as Notifications of Change as appropriate. 

1. Prepare regulatory submissions.
2. Responsible for the creation and assemblage of technical documentation on the products, including EU Technical Dossiers and Clinical Evaluation Reports.
3. Assists in the design of product labeling as related to regulatory compliance.
4. Provide support during internal and external audits.
5. With general guidance (and operating within company policy): determines the methods, work sequence and scheduling necessary to achieve objectives of assignments.
6. Read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
7. Edit and/or create documents to explain technologies, processes and products in multiple formats, such as; print, online and other electronic means.
8. Create new documentation by interviewing subject matter experts and conduct research needed to write and compile technically accurate content.
9. Edit technical documentation created by others; proofread, format and developmentally edit for intended audiences.
10. As needed, rewrite and clarify existing procedures.
11. Ability to clearly understand project design inputs and expected project output.
12. Ability to accurately determine time and materials required for a given project, accurately convey this information to management and work within the given project confines.
13. Must possess sufficient communication and writing skills to assure that adequate detail is correctly conveyed and appropriately presented.
14. Ability to coordinate and complete projects within the given deadlines and budgetary constraints.
15. Ability to produce output, which meets Engineering, QA, Production and customer/end user expectations.
16. Capable of maintaining effective and regular interactions with fellow department members and outside contractors/vendors.
17. Works closely with the Regulatory Submissions Assistant.
18. Required to be present in the work place during scheduled work hours.

1. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
2. Ability to write reports, business correspondence, and procedure manuals in English.
3. Ability to effectively present information and respond to question from groups of managers, clients, customers, the general public and board of directors.
4. Ability to respond to common inquiries or complaints from customers and regulatory agencies.
5. Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
6. Manual dexterity required.
7. Ability to clearly present information in written form including equipment qualifications, test protocols, technical reports, emails and informal memoranda.
8. Ability to function in a controlled environment regulated by FDA GMPs and ISO guidelines.
9. Ability to maintain accuracy, consistency and quality in a fast-paced, multi-task environment and be flexible in changing daily workload priorities as directed.
10. Ability to accurately perform detail oriented tasks.
11. Must possess excellent computer skills and be proficient with MS Word, Excel and Office or similar programs. In addition must be able to learn new programs and work with data processing, problem analysis.
12. Take initiative and make decisions, for projects.
13. Ability to add, subtract, multiply, and divide and ability to perform these operations using units of measure, using whole numbers, common fraction, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.

Prior experience in the Medical Device and/or Pharmaceutical related industry desired

Experience working with FDA GMP’s and ISO-13485