InVita Healthcare Technologies
Manager, Regulatory Affairs
InVita Healthcare Technologies, Baltimore, Maryland, United States, 21201
Manager, Regulatory Affairs
We are seeking a hands-on, detail-driven Manager of Regulatory Affairs to lead and execute regulatory strategy and submissions for our Class II SaMD (Software as a Medical Device) portfolio. This individual will be responsible for preparing and managing 510(k) submissions, interacting with FDA and other regulatory bodies, and maintaining regulatory compliance across the product lifecycle. You will play a pivotal role in both strategic planning and tactical execution, working closely with cross-functional teams in software engineering, quality assurance, compliance, and product management. This is an ideal opportunity for someone who is not only fluent in regulatory requirements but is also ready to roll up their sleeves to get submissions over the finish line. Key Responsibilities
Lead the preparation, authoring, and submission of 510(k) regulatory filings for Class II SaMD products. Serve as the regulatory point of contact for cross-functional teams including R&D, QA, and Product. Interpret and apply FDA regulations (21 CFR Part 820, Part 11), guidance documents, and ISO 13485 to support software product development and maintenance. Draft and maintain regulatory documentation, including labeling, risk assessments, and regulatory strategy documents. Work with QA to ensure Design History File (DHF) and Technical File completeness and audit readiness. Participate in internal and external audits and inspections, including those conducted by FDA or notified bodies. Monitor and evaluate changes in the regulatory landscape (e.g., FDA guidance or MDCG) that may impact product compliance. Provide tactical support for product development teams to ensure alignment with regulatory requirements from concept to release. Own the regulatory lifecycle management, including change assessments, renewals, and annual reporting. Assist in developing and maintaining regulatory SOPs and training programs. Required Qualifications
Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field. 5+ years of experience in regulatory affairs, with direct ownership of 510(k) submissions for Class II medical devices, ideally including software. Deep knowledge of SaMD regulations, FDA guidance on software, IEC 62304, ISO 14971, and other relevant standards. Proven ability to write and submit successful 510(k) filings. Excellent organizational, writing, and project management skills. Experience supporting cross-functional product teams in a tactical, execution-oriented capacity. Preferred Qualifications
RAC (US) certification or equivalent. Experience with global regulatory pathways. Exposure to QMS platforms and document control tools. Understanding of cybersecurity requirements and their impact on regulatory filings. Attributes for Success
Analytical thinker with strong troubleshooting and documentation skills. Strong communicator with a customer-first mindset. Comfortable balancing day-to-day operations with long-term projects. Values and champions collaboration and cross-functional coordination.
We are seeking a hands-on, detail-driven Manager of Regulatory Affairs to lead and execute regulatory strategy and submissions for our Class II SaMD (Software as a Medical Device) portfolio. This individual will be responsible for preparing and managing 510(k) submissions, interacting with FDA and other regulatory bodies, and maintaining regulatory compliance across the product lifecycle. You will play a pivotal role in both strategic planning and tactical execution, working closely with cross-functional teams in software engineering, quality assurance, compliance, and product management. This is an ideal opportunity for someone who is not only fluent in regulatory requirements but is also ready to roll up their sleeves to get submissions over the finish line. Key Responsibilities
Lead the preparation, authoring, and submission of 510(k) regulatory filings for Class II SaMD products. Serve as the regulatory point of contact for cross-functional teams including R&D, QA, and Product. Interpret and apply FDA regulations (21 CFR Part 820, Part 11), guidance documents, and ISO 13485 to support software product development and maintenance. Draft and maintain regulatory documentation, including labeling, risk assessments, and regulatory strategy documents. Work with QA to ensure Design History File (DHF) and Technical File completeness and audit readiness. Participate in internal and external audits and inspections, including those conducted by FDA or notified bodies. Monitor and evaluate changes in the regulatory landscape (e.g., FDA guidance or MDCG) that may impact product compliance. Provide tactical support for product development teams to ensure alignment with regulatory requirements from concept to release. Own the regulatory lifecycle management, including change assessments, renewals, and annual reporting. Assist in developing and maintaining regulatory SOPs and training programs. Required Qualifications
Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field. 5+ years of experience in regulatory affairs, with direct ownership of 510(k) submissions for Class II medical devices, ideally including software. Deep knowledge of SaMD regulations, FDA guidance on software, IEC 62304, ISO 14971, and other relevant standards. Proven ability to write and submit successful 510(k) filings. Excellent organizational, writing, and project management skills. Experience supporting cross-functional product teams in a tactical, execution-oriented capacity. Preferred Qualifications
RAC (US) certification or equivalent. Experience with global regulatory pathways. Exposure to QMS platforms and document control tools. Understanding of cybersecurity requirements and their impact on regulatory filings. Attributes for Success
Analytical thinker with strong troubleshooting and documentation skills. Strong communicator with a customer-first mindset. Comfortable balancing day-to-day operations with long-term projects. Values and champions collaboration and cross-functional coordination.