Regulatory Affairs Specialist - SaMD Software

Position Summary:

A Regulatory Affairs Specialist for Software 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). 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. The Regulatory Affairs Specialist collaborates across functions on new products and new technologies with a focus on Software to ensure software products meet safety efficacy & quality requirements and are readily available to patients in need.

Primary Duties:

• 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:

1. B.S. in Software Engineering or Chemical / Biochemical / Biomedical Engineering or related field.
2. Experience in medical device/IVD industry preferably in IVD or Medical Device engineering Product Development engineering or related functions.
3. Experience with rulesbased machine learning and artificial intelligence software devices (SaMD) preferred.

BioMrieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin age protected veteran or disabled status or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicants identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation falsification or material omission may result in the failure to receive an offer the retraction of an offer or if already hired dismissal. If you are a qualified individual with a disability you may request a reasonable accommodation in BioMrieuxs or its affiliates application process by contacting us via telephone atby email at or by dialing 711 for access to Telecommunications Relay Services (TRS).