Regulatory Affairs Specialist

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

WHAT YOU’LL NEED TO SUCCEED:

• 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.

WHAT WE’RE LOOKING FOR IN YOU:

• 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

Ultradent is an Equal Opportunity Employer. We are a global culture where differences and perspectives are sought after, welcomed, and embraced. We consider all qualified applicants fairly, based on their experience, skills, and potential to contribute to our team. Our core values – Integrity, care, quality, innovation, and hard work- guide us daily. These values, when balanced, shape our workplace culture and ensure that we remain focused on our vision while maintaining a professional and inclusive environment.
  
VEVRAA Federal Contractor: For more information please contact us at Recruiting@ultradent.com

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