Responsible for leading department level regulatory initiatives and provide regulatory in the areas of line extension new product development, maintenance of global registrations, creation of technical file documentation and quality systems support.
Essential Duties, Responsibilities and Qualifications may include the following. (Other duties may be assigned.)
Reviews and approves change orders, deviations, risk management documentation, non-conforming material reports as the Regulatory designee. Ensures compliance and no impact to existing regulatory licenses.
Provide department support during FDA, Notified body and other external or internal audits.
Compiles and submits regulatory documentation dossiers for new market registrations, significant change notifications, license renewals and annual registrations.
Acts as Project Manager for all regulatory activities related to global registrations, including requests for documentation to support international registrations. Completes any necessary regulatory certificates for exporting products
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.
North American Licensing:
Responsible for maintaining wholesale licenses certifications with the specific 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:
Support documentation and implementation of CIVCO Quality Systems, including ensuring compliance to FDA and international regulatory requirements such as EU, MDSAP and international regulatory requirements.
Supports root cause and action plan develop/execution on CAPA activities as required.
Create and maintain regulatory processes and work instructions as needed.
Supports Medical Device Reporting (MDR) and International Vigilance notifications as required.
Supports review of health hazard evaluations.
Support 510k documentation creation/submission for new product development.
Represents 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.
Education and/or Experience
Prefer a Bachelor’s degree in a related field from a four-year college or university; and one to three years related experience and/or training as a quality, biomedical, manufacturing, or regulatory professional.
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
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to toxic or caustic chemicals and risk of electrical shock. The noise level in the work environment is usually moderate.
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.
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About CIVCO Radiotherapy
Our mission is to improve outcomes for patients and healthcare providers worldwide by providing
high-quality, innovative, patient-centric radiotherapy solutions. Our vision is to be the leading innovative
partner in radiotherapy solutions worldwide.
Founded as Med-Tec, Inc. in 1982, our team has grown rapidly over the years, beginning as general machining for medical physicists to developing, manufacturing and distributing products for radiation therapy.
Med-Tec was purchased by Roper Technologies in 2005 and today we do business as CIVCO Radiotherapy. We show our commitment to our Mission and Vision by continuing to innovate internal solutions and build partnerships with like-minded companies who are innovating patient-centric, disruptive technologies.
We employ over 100 people worldwide who are committed to improving the patient journey. Our offices are located in Coralville (Corporate) and Orange City (Global Sales & Operations), Iowa.