Regulatory Affairs Engineer/Specialist

American Orthodontics • Sheboygan, WI

27d • Onsite

About The Position

The Regulatory Affairs Engineer/Specialist supports Engineering and Product Development teams in obtaining product registrations and advises project teams on regulatory requirements for product design, manufacturing, and labeling changes. The role supports domestic and international product registrations, regulatory submissions, product vigilance, and the development and maintenance of Quality Management System documentation.

This position is 100% in-office in Sheboygan, Wisconsin. The employee may also perform additional responsibilities as requested to achieve business objectives.

Requirements

• Demonstrated ability to lead multiple activities simultaneously.
• Demonstrated thoroughness and attention to detail.
• Strong written and verbal communication skills.

Nice To Haves

• A bachelor’s degree in Biomedical Engineering, Biology, Chemistry, Technical Communication, or a similar field from an accredited college or university is desired.
• Experience with medical devices or other highly regulated industries or products is desired.
• Experience with technical writing is desired.

Responsibilities

• Support Engineering and Product Development teams to successfully complete and obtain product registrations.
• Determine the regulatory submissions or documentation required for projects involving product design, manufacturing, or labeling changes.
• Advise project teams on pre-market regulatory requirements, export and labeling requirements, and 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 by reviewing customer complaints, reportable incident databases, and clinical literature.
• Identify relevant guidance documents, international standards, or consensus standards and communicate them through corporate policies and procedures.
• Write or update Quality Management System procedures, standard operating procedures, and work instructions to align with domestic or international laws, guidelines, or standards.
• Maintain current knowledge of relevant regulations, international standards, and guidance documents.
• Participate in internal and external audits.
• Perform additional responsibilities as requested to achieve business objectives.

What This Job Offers

• Job Type: Full-time