POSITION SUMMARY: The Regulatory Affairs and Quality Compliance Manager oversees the daily operations of USIOL’s regulatory department and ensures that USIOL’s medical devices are in compliance with all CE, FDA, and ISO regulations. The Regulatory Affairs and Quality Compliance Manager also works with department managers to ensure compliance with regulations. All maintenance of documentation relating to USIOL’s quality system in the regulatory department is the responsibility of the Regulatory Affairs and Quality Compliance Manager. The position reports directly to the QMR/Vice President.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Compiling and drafting technical documentation for regulatory submission.
- Maintaining quality management systems and quality documentation for the company.
- Conducting internal and external audits.
- Hosting FDA and other regulatory audits.
- Maintaining FDA and ISO compliance for all medically regulated devices.
- Preparing and submitting of regulatory reports.
- Staying abreast of and ensuring compliance with changes in federal regulations.
- Managing new product releases.
- Gaining clearance for the manufacture and importing of new products.
- Working in tandem with department managers to ensure compliance with regulations.
- Assisting with the on-boarding process by reviewing USIOL’s Quality Control Manual with new hires.
This position requires the employee to sit for up to eight hours a day. The Regulatory Affairs and Quality Compliance Manager may spend long hours sitting and using office equipment and computers.
This position will work in the same office as the Director of Sales, Director of Product Development, and the QMR/Vice President. The Regulatory Affairs and Quality Compliance Manager must meet with others on a regular basis. The position may spend long hours on the computer, which requires attention to detail and high levels of accuracy. There are a number of daily deadlines associated with this position.
AT-WILL EMPLOYER STATEMENT:
USIOL is an at-will employer. Regardless of any provision on this form, the company or employee may terminate the employment relationship at any time, for any reason, with or without cause or notice. Nothing in this employee job description or in any document or statement, written or verbal, shall limit the right to terminate employment at-will. No officer, employee, or representative of the company is authorized to enter into an agreement-express or implied-with any employee for employment for a specified period of time unless such an agreement is in a written contract signed by the President of the company.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:
USIOL is an Equal Employment Opportunity employer, and complies with federal, state, and local laws prohibiting discrimination. No person shall be discriminated against in employment, training, promotions, transfers, rates of pay, layoffs, any form of compensation or any term or condition of employment on the basis of race, gender, color, religion, national origin, age, marital status, disability, tobacco use, gender identity, sexual orientation, genetic information, military status, pregnancy, childbirth or lactation, status as a smoker or non-smoker, veteran status, or any other protected class under federal, state or local law.