Regulatory Affairs Specialist

Ultradent Products, Inc. • Salt Lake City, UT

4d

About The Position

Ultradent, a global name in oral health, is looking for a Regulatory Affairs Specialist. Regulatory Affairs Specialist performs specialized work assignments relative to the analysis, evaluation, preparation and submission of documentation to regulatory agency specifications for global market entry. You will also be responsible for development, review, and maintenance of internal documentation. The Regulatory Affairs Specialist is expected to encourage safe practices and enforce safety policies. Coordinate efforts associated with the preparation of regulatory documents or submissions for specified country(s) of responsibility. Prepares product technical documentation, to obtain and sustain global product approval. Identify, interpret, and maintain knowledge base of current regulations and regulatory guidance documents and standards Review and approve product labeling and promotional materials for compliance with cleared claims and with applicable regulations. Create or update standard operating procedures, tables, and forms Participate in project teams to develop regulatory strategies, testing requirements, and other documentation to ensure that new product regulatory submissions meet the company’s product launch timelines in all identified markets. Review and approve changes for design, manufacturing, and labeling to ensure compliance with national and international regulations. Mentor new hires as requested

Requirements

• Ability to work independently and/or with guidance from management to perform job functions.
• Working knowledge of national and international quality and regulatory laws and guidance.
• Ability to write detailed technical regulatory submissions and correspondence to regulatory agencies.
• Ability to write detailed clinical evaluation reports to current regulation requirement(s)
• Ability to work well in a cross-functional team setting.
• Computer skills including the ability to use MS Office Suite.
• Research and data analysis skills.
• Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
• Strong organizational and multi-tasking skills with a strong attention for detail.
• Knowledge of Ultradent’s products, systems, and processes
• Bachelor’s degree and 2-year minimum work experience in regulatory affairs or 4 years minimum work experience in regulatory affairs is ideal.

Nice To Haves

• Knowledge of Quality System Standards
• Computer skills including the ability to use MS Office Suite
• Experience submitting premarket submissions to the FDA (510(k))
• Participated in MDSAP/MDD/MDR/ISO 13485 audits
• Submitted EU Technical Documentation to a Notified Body
• Love the feeling of minty, fresh breath

Responsibilities

• Coordinate efforts associated with the preparation of regulatory documents or submissions for specified country(s) of responsibility.
• Prepares product technical documentation, to obtain and sustain global product approval.
• Identify, interpret, and maintain knowledge base of current regulations and regulatory guidance documents and standards
• Review and approve product labeling and promotional materials for compliance with cleared claims and with applicable regulations.
• Create or update standard operating procedures, tables, and forms
• Participate in project teams to develop regulatory strategies, testing requirements, and other documentation to ensure that new product regulatory submissions meet the company’s product launch timelines in all identified markets.
• Review and approve changes for design, manufacturing, and labeling to ensure compliance with national and international regulations.
• Mentor new hires as requested

Benefits

• Medical/Dental & Other Insurances (eligible the first of month after 60 days)
• Health Savings Account with employer contribution
• 401K Plan with employer matching contribution
• Employee access to discounted Ultradent products
• Excellent Paid Time Off (PTO) and Medical Time Off (MTO) account to support medical and military events
• Five days paid between Christmas and New Years
• Education Assistance
• Onsite Fitness Center

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level