Regulatory Affairs Specialist

Shift:

8 a.m. – 4 p.m., Monday – Friday

Job Summary:

The Regulatory Affairs Specialist supports regulatory compliance for medical device products manufactured across Genesis Dental Technologies (GDT) locations by maintaining quality system requirements, supporting product and process changes, and assisting with documentation, audits, and cleanroom compliance. This role partners closely with Quality, Engineering, and Manufacturing to ensure ongoing compliance with ISO standards, FDA regulations and applicable regulatory requirements.

Responsibilities and Duties:

• Support regulatory oversight for products manufactured across GDT locations, ensuring compliance with applicable regulatory requirements, standards, and internal procedures.
• Support the Quality Management System (QMS) in compliance with ISO 13485, FDA regulations and other applicable standards.
• Apply a strong working knowledge of electronic systems to support regulatory assessments, documentation reviews, and product change evaluations.
• Assist in the development, review, and maintenance of Standard Operating Procedures (SOPs), work instructions, and regulatory documentation to ensure accuracy and compliance.
• Support regulatory and quality activities related to cleanroom environments, including documentation, compliance activities, and coordination with Quality and Manufacturing teams.
• Collaborate cross-functionally with Quality, Engineering, Manufacturing, and other stakeholders to support pre-market and post-market regulatory activities.
• Support internal and external audits, including audit preparation, participation, and assistance with corrective and preventive action follow-up.
• Ensure assigned regulatory activities comply with internal procedures, applicable regulations, and external standards.
• All other duties as assigned.

Knowledge and Skills:

• Working knowledge of ISO 13485 and FDA quality system requirements for medical devices in a regulated environment.
• Working knowledge of IEC 60601-1, the international standard for safety and performance of medical electrical equipment.
• Understanding of electronics, electrosurgical devices and electromechanical systems sufficient to support regulatory assessments, documentation reviews, and product change evaluations.
• Knowledge of cleanroom requirements and controlled environment validation and certification practices.
• Strong attention to detail and organizational skills.
• Effective written and verbal communication skills, with the ability to collaborate cross-functionally.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency in Microsoft Word, Excel, and Outlook.
• Experience using QMS software (QT9 or similar preferred).

Education and Experience:

• Bachelor’s degree in a scientific or related discipline; or equivalent combination of education and experience.
• Minimum of 2 years of experience in a regulated environment such as medical devices, electronics manufacturing, quality, or regulatory support.
• Experience working with electronics, electrosurgical or electromechanical medical devices preferred.
• Experience supporting the creation, review, and maintenance of SOPs, work instructions, and controlled documentation.
• Familiarity with MET and supporting MET-related audits is a plus.
• Familiarity with cleanroom regulatory requirements is preferred.
• Experience supporting internal or external audits preferred.

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer
• Able to perform regular bending, twisting, and lifting to shelve
• Ability to lift and carry up to 30 pounds and push and/or pull at times
• Ability to walk frequently throughout the duration of the shift

Mark Anderson Companies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.

This job description is not intended to be all-inclusive. The employee may perform other related duties as necessary to meet the ongoing needs of the organization. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Work Location: In person