REGULATORY AFFAIRS/DOCUMENT CONTROL SPECIALIST

Ortho is a full line manufacturer of orthodontic products with a commitment to the future with investment in capital assets and cutting edge technology.  We are dedicated to service markets with strategies that introduce the newest trends and developments to practicing professionals worldwide. We are so confident in our product line and customer service that our Quality Statements reads; Ortho Organizers strives to exceed our customers' expectations and earn their confidence by delivering high quality products and services that are so good we'd use them on our own families.

A key factor in Ortho Organizers continued growth and success has been the ability to attract and keep good people.  Our dedicated, talented and hard-working employees have met many challenges and solved many issues to help the company continue to grow year after year.  At Ortho Organizers everyone is part of the team, with the same goal; to improve patient care and continue to “Advance the Future of Orthodonticsâ€� for generations to come.

Ortho Organizers employees enjoy a supportive work environment with an open-door management philosophy in addition to excellent benefits, competitive wages and advancement opportunities.  Ortho Organizers is an equal opportunity employer and treats each person with equality and fairness without regard to race, color, national origin, religion, marital status, physical or mental disability, sex, sexual preference, age or prior military experience.

Ortho Organizers is presently looking for new talent to join Regulatory Department as a Regulatory Affairs/Document Control Specialist.  Please read the job summary carefully, and if you have the skill set and expertise that aligns with the job requirements, please submit your resume for consideration. It is respectfully requested that NO PHONE INQUIRIES BE MADE REGARDING THIS POSITION.  Be assured that Ortho Organizers has a stringent recruiting process and should we determine there is a good match between your skilled work experience and the position requirements, we will contact you to move forward. Please be advised there is NO RELOCATION offered for this position.  PLEASE PROVIDE SALARY REQUIREMENTS AND/OR SALARY HISTORY. Thank you, we look forward to reviewing your resume!

 

REGULATORY AFFAIRS/DOCUMENT CONTROL SPECIALIST

 

SUMMARY:

Perform the following duties in a professional way, supporting Ortho Organizers’ Quality Policy. Must understand, follow and comply with regulatory requirements as applicable to various processes.  An understanding of FDA Quality System Regulations (21 CFR 820) and ISO Standards (ISO 13485) is required.

 

Oversees Ortho’s Regulatory programs and manages the Document Control Department supporting all departments to assure that all Quality System related elements comply to all regulations as specified by: state, federal and international regulatory agencies.  Performs the following duties in a professional way, supporting Ortho Organizers’ Quality Policy.

 

Must understand, interpret, implement and comply with regulatory requirements as applicable to various processes.  An understanding of FDA Quality System Regulations 21 CFR 820, ISO 13485:2003, Medical Device Directive 93/42/EEC and Canadian Medical Device Regulations SOR/98-282 is required, as well as applicable global harmonized standards and guidelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.

 

Regulatory:

· Supports management and implementation of the Quality System.

· Supports the duties of Regulatory Management Representative for regulatory agency visits.

· Serves as the official company Alternate Management Representative for all regulatory matters.

· Supports the Corrective Action / Preventative Action program.

· Manages planning, implementation, and execution of Internal Audit programs.

· Maintains all regulatory related registrations, certifications, and licensing.

· Maintains technical file system in conformance with regulatory requirements

· Provides regulatory support for domestic and international regulatory registration, licensing, and related requirements, preparing and submitting the necessary documents and data.  Maintains list of licenses and certifications.

· Supports product development and process improvement cross-functional teams as assigned, ensuring the applicable regulatory requirements and issues are understood and addressed by the team(s).

 

Document Control:

· Manages the Document Control department and staff and performs duties as needed.

· Manages the Change Control process.

· Manages and controls the product labeling database

· Maintains Job Training Records, Assures job specific training is provided and documented.

· Examines documents to verify compliance, completeness and accuracy of data.

· Confers with document originator and approvers to resolve discrepancies and compiles required changes to documents.

· Releases new, changes existing, obsoletes old, distributes copies and controls: Device Master Records (Technical Files), Work Instructions, Forms, Departmental Procedures and Quality System Procedures while maintaining all related files.

· Prepares documents, reports, spreadsheets, graphs, flowcharts, memorandum and schedules as needed.

 

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

EDUCATION and/or EXPERIENCE:

Bachelor’s degree or equivalent and three to five-years of related experience and/or training; or equivalent combination of education, training and experience.  Working knowledge of domestic and international regulatory requirements and document control practices applicable to medical device industry.  Experience leading document control and regulatory functions in the medical device industry.  Skilled in MS Office suite and MS Windows.  Experience with an Electronic Document Management System a plus.