Essential Duties, Responsibilities and Qualifications may include the following. (Other duties may be assigned.)
Support regulatory approvals for change orders, deviations and non-conforming material reports as needed. Upload necessary data to meet Universal Device Identifier (UDI) compliance. Provide department support during FDA, Notified body and other external or internal audits. Obtains notarizations from the Secretary of State and international embassies on documents utilized for export and product registrations when requested.
Lead regulatory efforts, using good business judgment to make sound determinations regarding regulatory responses and registrations. Be the Project Manager for all regulatory activities related to global registrations. Completes any necessary regulatory certificates for exporting products. Escalate any high risk or unclear issues to the Director of RA/QA for additional guidance and support. Participate in and apply training related to
regulatory environments in numerous regions of the world, keeping up to date on changes and informing the business of new requirements. Responds to customer requests for completing questionnaires and supplying information to support products being sold. Maintains product registration database and reports quarterly on expiring global licenses. Responsible for maintaining existing product registrations for licenses held by CIVCO facilities to keep them current. Responsible for reporting quarterly on expiring registrations. Coordinates submission of foreign registration documentation to Original Equipment Manufacturers (OEMs), external market authorization holders and/or distributors. Supports export process by providing Certificates of Origin to identify the product families being shipped out and their export classifications.
North American Licensing:
Responsible for maintaining wholesale licenses certifications with the specific states within the United States which have this requirement for medical devices. Completes all applications and ensure annual renewals are filed and paid to avoid expiration of certification.
Quality Systems Support:
Supports execution of compliance initiatives. Performs internal audits of the quality system as assigned. May be asked to assist with gathering and testing of samples or other quality and/or CAPA activities as needed.
Supports drafting and approval of health hazard assessment documentation as needed to support NCMR’s, complaints, and vigilance reporting activities.
Support product 510k adoptions to support release as needed. As needed, may represent Regulatory at Design Reviews, device releases, and other activities requiring Regulatory approvals.
Technical File Creation/Maintenance:
Updates TFA files with respect to declarations of conformance, master listings, medical device directive checklists, and assisting with clinical evaluation reporting data gathering.
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
Four-year degree in engineering or related technical field and one to three years related experience and/or training; or equivalent combination of education and experience. One to three years related experience and/or training as a quality, biomedical, manufacturing, or regulatory professional preferred.
Working knowledge of Quality System Regulations and ISO Standards. Demonstrated understanding of quality tools. Demonstrated interpersonal and communication skills. Demonstrated understanding of verification and validations for design, processes, equipment and components. Ability to research and define requirements for gaining entry to foreign markets and maintaining licensing in domestic regions. Good communication to ensure the appropriate information is available to solve a problem.
CIVCO Radiotherapy is an equal opportunity affirmative action employer.