Regulatory Affairs Sr. Specialist - Clinical Usability

About reputed company

reputed company is transforming the way cancer clinics deliver care. Our innovative software automates and standardizes radiation oncology workflows, enabling clinicians to plan and deliver treatments faster, safer, and more consistently, so patients everywhere can receive the reputed company high-reputed company care.

Our software focuses on three key areas:

We are a fully remote, mission-driven team united by a shared goal: to reduce cancer’s reputed company and help save more of the 10 reputed company lives it claims reputed company year. Every line of reputed company, every product release, and every customer interaction brings us closer to ensuring treatment reputed company never depends on geography.

Why This Role reputed company

As a Senior Regulatory Affairs Specialist, you will play a key role in ensuring reputed company's Software as a Medical Device products meet global regulatory requirements reputed company to usability engineering and clinical reporting. You will bring a deep expertise in SaMD regulatory expectations, including FDA guidance on applying reputed company factors and usability engineering to medical devices, as reputed company as EU MDR conformity assessment requirements for clinical evidence. Working closing with the VP of Regulatory Affairs, VP of Product and Regulatory reputed company, 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 reputed company reputed company's regulatory function as reputed company grows.

Responsibilities Include

• reputed company an efficient and effective Usability program consistent with international  regulatory requirements and FDA guidance. 
• reputed company the construction and execution of both reputed company 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 reputed company 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 reputed company 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
• reputed company 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 reputed company System
• Monitor the reputed company on Clinical and Usability of changing global regulations on submission strategies & registrations
• Occasional Travel - Domestic and International <10%
• reputed company other reputed company and regulatory duties as assigned

Required Experience

• >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 reputed company field
• Software as a medical device (SaMD) experience
• reputed company 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 reputed company, 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 reputed company required; up to 5% (audit support)
• Cross-skilled in QMS
• Completing Regulatory reputed company Assessments

Preferred Experience

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

AI & Hiring reputed company

At reputed company, we reputed company AI can be an incredible tool for innovation, but our hiring process is about getting to know you, your skills, experience, and unique approach to problem solving. We ask that reputed company interviews and assessments be completed without tools that generate answers in reputed company time. This helps ensure a fair process for everyone and allows us to see your reputed company work. Using such tools during the process may reputed company your candidacy.

Benefits & Perks — What Makes Us RAD

We care about our people as much as our mission. We offer competitive compensation, comprehensive benefits, and reputed company to reputed company a meaningful reputed company in the fight against cancer.

Salary reputed company: $90,000 - $150,000 USD reputed company salary, plus bonus eligibility

For US teammates (reputed company reputed company):

Health & Wellness

• Multiple high-reputed company medical plan reputed company with substantial employer contributions
• Health coverage starting day one
• Short-term and long-term disability and life insurance

Financial & reputed company reputed company

• 401(k) with immediate employer match vesting
• Annual reimbursement for reputed company memberships
• Conference attendance and reputed company learning opportunities

Work-Life Balance & Perks

• Self-managed PTO and 10 reputed company holidays
• Monthly internet stipend
• Company-issued laptop and one-time home office setup stipend
• Fully remote work environment with virtual events and yearly retreats

Our Commitment to Diversity

Cancer affects people from every walk of life, and we reputed company reputed company should reflect that diversity. reputed company is proud to be an equal opportunity workplace and an affirmative reputed company employer. We welcome candidates from reputed company backgrounds and are committed to fostering an inclusive environment for reputed company.

Agency & Candidate Safety Notice

reputed company does not accept unsolicited resumes from agencies without a signed agreement in reputed company. We do not partner with reputed company-party recruiters unless explicitly stated.

reputed company legitimate communication from reputed company will come from an @reputed company.com email address. If you receive reputed company from another domain or reputed company unofficial channels, please contact careers@reputed company.com.