Regulatory Affairs Engineer/Specialist
American Orthodontics • Sheboygan, WI28d • Onsite
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Regulatory Affairs Engineer/Specialist
American Orthodontics•Sheboygan, WI
•Onsite
About The Position
This role supports Engineering and Product Development teams in successfully completing and obtaining product registrations. The position involves determining the types of regulatory submissions or documentation required for projects with product design, manufacturing, or labeling changes. The individual will advise project teams on pre-market regulatory requirements, export and labeling requirements, and clinical study requirements. This role also requires communication with customers and regulatory agencies to support product registrations, and the creation, management, and organization of technical documentation in a document control system for domestic and international registrations. Additionally, the position involves responding to questions from regulatory agencies, managing projects related to maintaining product registrations, supporting product vigilance activities, identifying relevant guidance documents and international standards, and writing/updating Quality Management System procedures. The role requires maintaining current knowledge of relevant regulations and participating in audits. This position is 100% in-office in Sheboygan, WI.
Requirements
- Demonstrated ability to lead multiple activities simultaneously
- Demonstrated thoroughness and attention to detail
- Strong written and verbal communication skills
Nice To Haves
- Bachelor’s degree in Biomedical Engineering, Biology, Chemistry, Technical Communication, or similar field from an accredited college or university
- Experience with medical devices or other highly regulated industries/products
- Experience with technical writing
Responsibilities
- Support Engineering and Product Development teams to successfully complete and obtain product registrations
- Determine the types of regulatory submissions or documentation required for projects with product design changes, manufacturing changes, or labeling changes
- Advise project teams on subjects such as pre-market regulatory requirements, export and labeling requirements, and/or clinical study requirements
- Communicate with customers and regulatory agencies to support product registrations
- Create, manage, and organize technical documentation in a document control system for domestic and international registrations
- Respond to questions from regulatory agencies and prepare additional documentation as requested
- Manage projects related to maintaining product registrations in domestic and international markets
- Support product vigilance activities through review of customer complaints, reportable incident databases, and clinical literature
- Identify relevant guidance documents, international standards, or consensus standards and ensure these are communicated through corporate policies and procedures
- Write and/or update Quality Management System procedures, standard operating procedures, and/or work instructions to align with domestic or international laws, guidelines, or standards
- Maintain current knowledge base of relevant regulations, international standards, and/or guidance documents
- Participate in internal and external audits
- Perform additional responsibilities as requested to achieve business objectives
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
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