Manager, Regulatory Affairs

El Camino Health; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Paid holidays and time off

401(k) with company match

Employee Stock Purchase Plan

Job summary

El Camino Health is looking for a regulatory affairs professional to develop and execute strategies for medical devices. This full-time remote position requires 8-10 years of regulatory experience, including authorship of 510(k)s and FDA submissions.

The ideal candidate will demonstrate strong project management and problem-solving skills, and have experience in medical device regulations. Competitive salary package includes benefits like insurance and a 401(k) plan.

Qualifications

• 8-10 years of regulatory affairs experience with a Bachelor's degree, or 6 years with a Master's degree.
• Experience with Software as a Medical Device (SaMD).
• Authorship of 510(k)s and managing FDA reviews required.
• Experience with wearable medical devices preferred.

Responsibilities

• Develop regulatory strategies for medical devices.
• Manage regulatory associates and team planning.
• Lead FDA submissions for wearable devices.
• Prepare domestic and international regulatory filings.

Skills

Regulatory strategies

Project management

Problem-solving skills

Communication skills

Education

BA or BS degree in engineering, life sciences, or related field

Tools

FDA submissions

ISO 13485

IEC 62304

HIPAA

Job description

About This Role

• Developing and executing regulatory strategies for new and modified medical devices in line with business objectives
• Managing regulatory associates, responsible for team’s work planning, guidance, execution and talent development
• Leading FDA submissions (510(k) or pre-submissions) with the team, including wearable devices and AI Software as a Medical Device (SaMD) products
• Serving as Key Regulatory SME and reviewing & approving advertising and promotional materials to ensure regulatory compliance
• Defining regulatory strategy and processes for product life cycle management
• Leading EU MDR Technical Documentation and other international submissions for wearable devices and SaMD
• Developing regulatory tools and matrices to enhance team efficiency and capabilities as needed
• Acting as regulatory expert in AI, SaMD, Cybersecurity, collaborating with stakeholders to establish necessary processes for regulation compliance
• Preparing international and domestic regulatory filings/registrations in line with established project timelines
• Interacting with regulatory authorities during development and review processes to ensure submission clearance
• Reviewing and approving product design changes to maintain regulatory compliance for significant changes
• Authoring or revising SOPs to improve regulatory compliance within the Quality System
• Monitoring the impact of changing global regulations on submission strategies & registrations
• Supporting external and internal audits
• Performing other regulatory-related duties as assigned

Qualifications

• BA or BS degree in engineering, life sciences, or a related field required
• >8‑10 years minimum of US and/or EU regulatory affairs experience with a Bachelor’s degree; 6 years minimum of US and/or EU regulatory affairs experience with a Master’s degree
• Demonstrated competency in operating under 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA and other medical device industry standards
• Software as a medical device (SaMD) experience required
• New product development experience required
• Authorship of 510(k)s and experience managing FDA reviews to gain clearance required
• Demonstrated competency in developing risk‑based regulatory strategies required
• Wearable medical device experience preferred
• Familiarity with global medical device regulations (LATAM, Asia Pac, EMEA, etc.) preferred
• Audit support experience preferred
• Strong project management skills
• Exceptional problem‑solving skills
• Exceptional organizational skills
• Exceptional communication (written and oral) skills
• Willingness to travel when required, approximately 5‑10%

Benefits

• Full‑time position with competitive salary package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off
• 401(k) with company match
• Employee Stock Purchase Plan
• Annual organizational/cultural committee events and more

Location

Remote – US

EEO Statement

iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws. iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system.