Regulatory Affairs Sr. Specialist - Clinical Usability

Radformation

2d•$90,000 - $150,000•Remote

About The Position

As a Senior Regulatory Affairs Specialist, you will play a key role in ensuring Radformation's Software as a Medical Device products meet global regulatory requirements related to usability engineering and clinical reporting. You will bring a deep expertise in SaMD regulatory expectations, including FDA guidance on applying human factors and usability engineering to medical devices, as well as EU MDR conformity assessment requirements for clinical evidence. Working closing with the VP of Regulatory Affairs, VP of Product and Regulatory Principal, you will help drive completion of critical usability and clinical deliverables, support regulatory compliance across the product life cycle, and strengthen the processes needed to scale Radformation's regulatory function as the company grows.

Requirements

>8 years of regulatory affairs experience with a Bachelor's degree (B.A/B.S. required); >6 years of experience with a Master's or other advanced degree in a related field
Software as a medical device (SaMD) experience
Lead and/or author 510k or MDR submission experience
Experience in creating or contributing to usability studies, Analyzing Results and Generating Repots
Experience Creating and/or Contributing to CER/CEP/PMCF and PMS activities, specifically in relation to EU-MDR Medical Devices
Familiarity with global medical device regulations; 21 CFR 820 (QMSR), CMDR, EU MDD/MDR, ASIA PAC, LATAM, etc.
Demonstrated understanding of ISO 13485, MDSAP, ISO 14971, GSPR, GDPR, HIPPA and other international regulations/directives/standards
Exceptional communication (written and oral) skills
Experience writing content for regulatory submissions (CER/CEP/Tech Papers/Reports/RBA...)
Willingness to travel when required; up to 5% (audit support)
Cross-skilled in QMS
Completing Regulatory Impact Assessments

Nice To Haves

Product development experience
Strong project management skills
Risk Management Processes and Deliverables
Post Market/Adverse Event Evaluation and Reporting
RAC Certification is a plus

Responsibilities

Develop an efficient and effective Usability program consistent with international regulatory requirements and FDA guidance.
Lead the construction and execution of both formative and summative usability activities for SaMD applications
Generate Regulatory Submission content for Usability Engineering, including Plans, Reports, Use Error Analysis and Traceability
Work with customer contact and product application specialists to oversee the execution of Usability studies
Map existing Clinical Deliverables to global requirements for clinical evidence and reporting
Work with existing Clinical Affairs Medical Physicist to Champion efficiency improvements in our CEP/CER/PMCF and PMS processes and deliverables
Drive execution of PMCF and PMS activities and reporting
Represent Radformation in Compliance Audits and Conformity Assessments, specifically regarding usability and Clinical documentation
Assess New Feature and Product planning documents to determine potential Clinical and Usability needs
Collaborate with cross-functional partners in driving and implementing new processes, primarily but not limited to Usability Engineering, Clinical Affairs and Post Market Surveillance
Interact with regulatory authorities as needed during the development and review process to ensure submission approval
Author or revise SOPs to improve regulatory compliance of the Quality System
Monitor the impact on Clinical and Usability of changing global regulations on submission strategies & registrations
Occasional Travel - Domestic and International <10%
Perform other quality and regulatory duties as assigned

Benefits

Multiple high-quality medical plan options with substantial employer contributions
Health coverage starting day one
Short-term and long-term disability and life insurance
401(k) with immediate employer match vesting
Annual reimbursement for professional memberships
Conference attendance and continued learning opportunities
Self-managed PTO and 10 paid holidays
Monthly internet stipend
Company-issued laptop and one-time home office setup stipend
Fully remote work environment with virtual events and yearly retreats