Idea Evolver
Company Overview
IE is a Consumer Healthcare Technology and Pharmaceutical Launch Partner dedicated to accelerating safe access to life‑changing treatments. Our notable roster of clients comprises heavyweights in the industry like AstraZeneca, Petros Pharma, Cadence Health, Horizon Therapeutics, and United Therapeutics.
Position Overview We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs to join our team working in SaMD. As the regulatory leader, you will be responsible for driving the regulatory strategy and execution of innovative products in the Software as a Medical Device space. You will have the opportunity to define regulatory requirements and policies that affect product requirements, create product roadmaps, and prioritize features based on client feedback and business objectives.
Primary Duties
Serve as client‑facing regulatory lead to bring SaMD products to the US market with FDA approval.
Provide regulatory expertise, guidance, and direction, inclusive of potential risks and strategic opportunities, to regulatory affairs and cross‑functional leadership.
Evaluate proposed product modifications for regulatory impact and complete regulatory assessments.
Drive regulatory compliance for successful FDA 510(k) submissions.
Support RA specialists in preparation and submission of 510(k)s, including any follow‑up and Note to File.
Support Business Unit regulatory affairs teams to interact with FDA in support of ACNU clearance activities.
Oversee QA/RA team to provide support for ensuring company compliance with all applicable quality, regulatory, and statutory requirements.
Serve as Management Representative leading and promoting company initiatives in support of Idea Evolver’s Quality Policy and Objectives through continuous improvement of the Quality Management System (QMS).
Oversee CAPA, Change Management, Internal and External Audits, Management Review & Post‑Market Surveillance needs.
Ensure the organization is meeting regulatory and quality objectives.
Ensure compliance to Design Control & SDLC process requirements at a project level.
Serve as the main contact between Idea Evolver and customer to support regulatory submissions, communications with the FDA and supporting audits.
Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards for the US and assist in the dissemination of this information.
Ensure cross‑functional teams receive communication regarding project milestones to support their daily work.
Interface with appropriate internal and external resources to ensure on‑time delivery for project and accurately communicate project risks, impacts and mitigation.
Lead teams in preparation for Phase Gate Reviews and decisions.
Qualifications
10+ years of experience in regulatory and quality management, preferably in the SaMD space. ACNU expertise is a huge bonus.
Sophisticated understanding of cloud‑based software.
Understanding of regulatory implications of machine learning models.
Experience working with medium to large‑sized businesses in a client‑facing role.
Highly motivated, independent individual with strong organizational skills and a thorough attention to detail.
Strong analytical and problem‑solving skills with the ability to make data‑driven decisions.
Excellent written and verbal communication skills, with the ability to present complex ideas in a clear and concise manner.
A proven track record of delivering successful products on time and within budget.
Bachelor’s degree required.
Compensation and Benefits
Competitive Salary
Health and wellness benefits
401(k) with company matching
20 paid days off plus holidays
If you are passionate about using technology to improve healthcare outcomes and have a strong track record of delivering innovative products, we encourage you to apply for this exciting opportunity. Join our dynamic and growing team to make a meaningful impact on the healthcare industry.
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Position Overview We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs to join our team working in SaMD. As the regulatory leader, you will be responsible for driving the regulatory strategy and execution of innovative products in the Software as a Medical Device space. You will have the opportunity to define regulatory requirements and policies that affect product requirements, create product roadmaps, and prioritize features based on client feedback and business objectives.
Primary Duties
Serve as client‑facing regulatory lead to bring SaMD products to the US market with FDA approval.
Provide regulatory expertise, guidance, and direction, inclusive of potential risks and strategic opportunities, to regulatory affairs and cross‑functional leadership.
Evaluate proposed product modifications for regulatory impact and complete regulatory assessments.
Drive regulatory compliance for successful FDA 510(k) submissions.
Support RA specialists in preparation and submission of 510(k)s, including any follow‑up and Note to File.
Support Business Unit regulatory affairs teams to interact with FDA in support of ACNU clearance activities.
Oversee QA/RA team to provide support for ensuring company compliance with all applicable quality, regulatory, and statutory requirements.
Serve as Management Representative leading and promoting company initiatives in support of Idea Evolver’s Quality Policy and Objectives through continuous improvement of the Quality Management System (QMS).
Oversee CAPA, Change Management, Internal and External Audits, Management Review & Post‑Market Surveillance needs.
Ensure the organization is meeting regulatory and quality objectives.
Ensure compliance to Design Control & SDLC process requirements at a project level.
Serve as the main contact between Idea Evolver and customer to support regulatory submissions, communications with the FDA and supporting audits.
Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards for the US and assist in the dissemination of this information.
Ensure cross‑functional teams receive communication regarding project milestones to support their daily work.
Interface with appropriate internal and external resources to ensure on‑time delivery for project and accurately communicate project risks, impacts and mitigation.
Lead teams in preparation for Phase Gate Reviews and decisions.
Qualifications
10+ years of experience in regulatory and quality management, preferably in the SaMD space. ACNU expertise is a huge bonus.
Sophisticated understanding of cloud‑based software.
Understanding of regulatory implications of machine learning models.
Experience working with medium to large‑sized businesses in a client‑facing role.
Highly motivated, independent individual with strong organizational skills and a thorough attention to detail.
Strong analytical and problem‑solving skills with the ability to make data‑driven decisions.
Excellent written and verbal communication skills, with the ability to present complex ideas in a clear and concise manner.
A proven track record of delivering successful products on time and within budget.
Bachelor’s degree required.
Compensation and Benefits
Competitive Salary
Health and wellness benefits
401(k) with company matching
20 paid days off plus holidays
If you are passionate about using technology to improve healthcare outcomes and have a strong track record of delivering innovative products, we encourage you to apply for this exciting opportunity. Join our dynamic and growing team to make a meaningful impact on the healthcare industry.
#J-18808-Ljbffr