Regulatory Affairs Specialist, Cleveland, OH
Support the team in the development and execution of regulatory strategies.
- Review routine change orders and product complaints for accuracy, effectiveness, and compliance.
- Complete regulatory assessments for product and process changes and non-conforming material reports.
- Support and prepare sections of regulatory submissions, including but not limited to IDEs and 510(k)s.
- Maintain a database of standards, regulations, and FDA guidance documents.
- Remain current with new and changing regulatory requirements in US, EU, Canada and ROW, communicate those requirements internally, assess impact on procedures and operations, and implement internal changes as necessary.
- Ensure compliance with pre- and post-market regulatory requirements, including assessment of product complaint reportability and submission of any Medical Device Reports.
- Support scheduled and unannounced notified body audits and FDA inspections.
- Bachelor’s Degree in Engineering, Science, or Healthcare related field.
- Minimum of 2 years of medical device experience including knowledge of related US regulatory requirements OR a Master’s Degree in Regulatory Affairs with 0-2 years of related experience.
- Must have an understanding of US medical device regulatory requirements.
- Must be an effective oral and written communicator and be able to lead meetings and clearly present ideas.
Why Join Our Team?
- Entrepreneurial work environment
- Small, collaborative office environment
- Competitive compensation and benefits
- Employee Wellness Program