Title: Regulatory Affairs Specialist
Location: Waukegan, IL
A Regulatory Affairs Specialist who can handle Regulatory requirements related to EUMDR for a Software as a Medical Device (SaMD).
- Perform gap analysis to understand the currents gaps in regulatory documentation with respect to EUMDR.
- Assess acceptability and completeness of documentation.
- Identify unmet needs and provide feedback.
- After assessing the gaps, compile , complete and organize documentation to ensure compliance to EU MDR requirements and support in submissions.
- Work closely with cross-functional teams.
- Interact with regulatory authorities and execute regulatory processes/submissions; provide feedback on submission review progress & questions; coordinate, write & review answers to competent authority questions; and report on issues.
- Must be an SME who can stay current with respect to regulatory changes & developments needed for submission requirements & processes.
- Participate in Design Control projects to advise responsible personnel on regulatory requirements & develop options with recommendations; develop software regulatory strategies; continually assess project output & impacts on regulatory the defined strategy / product launch date
- Understand & investigate regulatory history of similar products in order to assess regulatory implications for new products or changes to existing products
- Provide regulatory review and / or approval of product verification & validation documents, product labels, instructions for use, and advertising / promotional materials
- Assist in the development and review of procedures.
Knowledge, Experience and Skills:
- B.S. in Software Engineering, Biomedical Engineering, or related field.
- 5+ years of experience in medical device industry, preferably in product development or engineering functions.
- Strong knowledge of standards - ISO 13485, ISO 82304, ISO 14971
- Experience Software or SaMD preferred.
- Experience of having worked on EU MDR documentations.