Regulatory Compliance Specialist
About The Position
Regulatory Compliance Specialist Ultradent, a global name in oral health, is looking for a Regulatory Compliance Specialist . Regulatory Compliance Specialist performs specialized work assignments relative to the analysis and evaluation of regulatory requirements for maintaining global compliance. You will also be responsible for development, review, and maintenance of internal documentation including safety data sheets. This role is ideal for professionals who seek a detail orientated role and have a keen interest in regulatory frameworks, risk management, and continuous improvement. Monitor and interpret regulatory requirements relevant to our industry, including national and international requirements. Identify, interpret, and maintain knowledge base of current regulations and regulatory guidance documents and standards Stay informed of changes in laws, regulations, and industry trends that may impact company operations Maintaining accuracy of SDSs Contribute to chemical characterization of products based on regulatory concern areas such as REACH, PFAS, Prop 65, animal derivatives, latex, and similar requirements
Requirements
- Ability to work independently and/or with guidance from management to perform job functions.
- Working knowledge of QMS regulations, Good Documentation Practices, and medical device manufacturing environments.
- Basic working knowledge of FDA and MDSAP regional regulatory requirements.
- Exposure to Quality/ and/or Regulatory related projects.
- 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 1-year minimum work experience in regulatory or quality, or 5 years relevant work experience is ideal.
Nice To Haves
- Knowledge of Quality System Standards
- Strong attention to detail and willingness to learn
- Participated in MDSAP/MDD/MDR/ISO 13485 audits, preferred
- Love the feeling of minty, fresh breath
Responsibilities
- Monitor and interpret regulatory requirements relevant to our industry, including national and international requirements.
- Identify, interpret, and maintain knowledge base of current regulations and regulatory guidance documents and standards
- Stay informed of changes in laws, regulations, and industry trends that may impact company operations
- Maintaining accuracy of SDSs
- Contribute to chemical characterization of products based on regulatory concern areas such as REACH, PFAS, Prop 65, animal derivatives, latex, and similar requirements
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
