POSITION SUMMARY: The Director of Regulatory Affairs and Quality Assurance is a hands-on, senior leadership position, which oversees and executes the daily operations and corporate strategy of US IOL’s regulatory department. The Director of Regulatory Affairs and Quality Assurance ensures that US IOL’s medical devices are in compliance with all CE, FDA, ISO, and MDSAP regulations. The position collaborates with cross-functional teams and production managers to ensure compliance with regulations and ensures timely launch of new devices. This position must work and think independently; operating as the company’s regulatory expert with minimal to no guidance. All maintenance of documentation relating to US IOL’s quality system in the regulatory department is the responsibility of the Director of Regulatory Affairs and Quality Compliance. The position reports to the COO.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Defines and executes US IOL's RA/QA activities to support business and corporate strategy.
2. Leads the compilation and submission of technical files, 510ks, design dossiers, and other regulatory documents.
3. Builds and develops a high performing regulatory affairs and quality assurance team.
4. Oversees the quality management systems and quality documentation for the company.
5. Establishes, manages, and maintains compliance with other global regulatory standards, including, but not limited to: 21 CFR 820, ISO 13485, MDSAP, ISO 14971, and other applicable international standards.
6. Conducts internal and external audits.
7. Hosts FDA and other regulatory audits.
8. Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to medical device quality systems and management.
9. Provides strategic direction for new product development regulatory strategies aimed at improving time to market globally. Works with the product development, marketing, and sales teams through the design, development, and launch of new devices.
10. Working in tandem with department managers to ensure compliance with regulations.
11. Assisting with the on-boarding process by reviewing US IOL’s Quality Control Manual with new hires.
12. Managing new product releases.
13. Staying abreast of and ensuring compliance with changes in federal regulations.
14. Gaining clearance for the manufacture and import of new products.
MINIMUM JOB REQUIREMENTS:
EDUCATION AND EXPERIENCE:
1. Bachelor’s Degree is required, preferably in a related field such as science or engineering. A Master’s Degree is preferred.
2. Minimum of ten (10) years in a regulatory/quality compliance (FDA or ISO).
3. Minimum of five (5) years of supervisory experience.
4. Extensive knowledge with ISO 13485:2016.
5. Candidates without experience in submitting and gaining approval of 510ks or class IIb CE marks will not be considered.
KNOWLEDGE, SKILLS, AND ABILITIES:
1. Attention to detail.
2. Effective at balancing long-term and short-term projects.
3. Ability to analyze complex regulations and ensure that USIOL is in compliant with those regulations.
4. Effective communicator with exceptional organizational skills.
5. Experience in managing significant regulatory projects and providing visibility of progress to executive leadership.
6. Expert level Microsoft Office skills.
7. Experience with implementing quality software is preferred.
This position requires the employee to sit for up to eight hours a day. The Director of Regulatory Affairs and Quality Compliance 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 Director of Regulatory Affairs and Quality Compliance 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.
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About U.S. IOL, Inc.
US IOL manufactures and provides the finest Intraocular Lenses, Viscoelastic Gels, Sutures and Punctum Plugs.
US IOL Inc. was established in 1985 in Lexington, Kentucky. Our primary goal was, and continues to be, the manufacture of quality intraocular lenses for distribution worldwide. Our product range has grown to include viscoelastic, punctum plugs and sutures to the expanded acrylic hydropholic lens line.