A Regulatory Affairs Specialist is an individual contributor role that serves as the Subject Matter Expert (SME) for regulatory requirements as related to global Software as a Medical Device (SaMD), and/or medical device systems. As an individual coordinator, a Regualtory Affairs Specialist defines regulatory strategies for key markets, and is the primary regulatory point of contact on development projects involving SaMD and/or medical device systems. The Regulatory Affairs Specialist collaborates across functions on new products and new technologies with a focus on software and/or medical device systems to ensure our products meet safety, efficacy & quality requirements, and are readily available to patients in need.
- Compile & organize the content of regulatory applications & files; assess acceptability & completeness of documents; identify unmet needs & provide feedback; and ensure filing & timely retrieval of documents
- 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
- Conduct research to stay current / apply regulatory changes & developments on 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 a related field.
- 3+ years of experience in medical device/IVD industry, preferably in IVD or Medical Device engineering, Product Development engineering or related functions.
- Experience with rules-based, machine learning and artificial intelligence software devices (SaMD) preferred.