Regulatory Affairs Engineer/Specialist

American OrthodonticsSheboygan, WI

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Overview

Schedule

Full-time

Education

Engineering (PE)

Career level

Senior-level

Remote

On-site

Job Description

Duties and 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
This position is 100% in-office in Sheboygan, WI

Qualifications

Bachelor's degree in Biomedical Engineering, Biology, Chemistry, Technical Communication, or similar field from an accredited college or university desired
Experience with medical devices or other highly regulated industries/products desired
Experience with technical writing desired
Demonstrated ability to lead multiple activities simultaneously
Demonstrated thoroughness and attention to detail
Strong written and verbal communication skills

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FAQs About Regulatory Affairs Engineer/Specialist Jobs at American Orthodontics

What is the work location for this position at American Orthodontics?

This job at American Orthodontics is located in Sheboygan, WI, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at American Orthodontics?

Employer has not shared pay details for this role.

What employment applies to this position at American Orthodontics?

American Orthodontics lists this role as a Full-time position.

What experience level is required for this role at American Orthodontics?

American Orthodontics is looking for a candidate with "Senior-level" experience level.

What education level is required for this job?

The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.

What is the process to apply for this position at American Orthodontics?

You can apply for this role at American Orthodontics either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.