Full-Time

Regulatory Affairs Samd Specialist

Updated on 12/7/2024

Resmed

Resmed

5,001-10,000 employees

Develops cloud-connected medical devices for chronic diseases

Enterprise Software
Healthcare

Compensation Overview

$85k - $129kAnnually

Mid

Remote in USA

Remote role with a preference for West Coast hours.

Category
Risk & Compliance
Legal & Compliance
Requirements
  • Bachelor's degree (technical or software background preferred) from four-year college or university; in addition to minimum three (3) to five (5) years related experience or equivalent education and experience.
  • Experience in health software or medical device industry.
  • Experience with US premarket device submissions and EU MDR highly preferred.
  • Must be detail oriented & highly organized.
  • Ability to work independently and exercise judgment with limited supervision.
  • Must possess strong interpersonal communication skills.
  • Ability to prioritize workload with limited supervision.
  • Must demonstrate teamwork building skills in & outside department.
  • Ability to exercise judgment.
Responsibilities
  • Execute regulatory strategies and provide regulatory guidance and support for commercial launch and throughout the total product lifecycle for both software as a medical device (SaMD) and non-medical software products.
  • Participate in Digital Provider Product Development teams, by providing regulatory strategy, timelines and deliverables; work closely with product development engineering, data science, clinical, marketing, quality and regional regulatory functions to assure appropriate requirements are defined for the specific device type/classification, claims and target patient population.
  • Prepare (develop submission content and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances for SaMD products in accordance with regulatory strategic plan.
  • Work closely and collaborate with stakeholders on processes related to software and AI/ML-enabled products.
  • Responsible for attending such conferences, seminars, professional meetings, and other public forums as are relevant to the regulatory interests of ResMed.
  • Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry. Evaluates new and changing regulations and provides feedback to global regulatory network on the impact to the quality system and regulatory submissions for that region.
  • Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including, including SaMD, AI/ML, EU MDR, FDA regulations and policies applying to medical devices including, 510(k)s, 21 CFR 820, 21 CFR 801, global registration, etc.

ResMed develops medical devices and software platforms that help treat and manage conditions like sleep apnea and chronic obstructive pulmonary disease (COPD). Their products are cloud-connected, allowing for better monitoring and management of patients' health. ResMed's offerings include both medical devices and software subscriptions, which provide ongoing support and services. Unlike many competitors, ResMed focuses on reducing hospital visits and healthcare costs, making their solutions beneficial for both patients and healthcare systems. The company's goal is to improve the quality of life for patients while providing effective care solutions.

Company Stage

IPO

Total Funding

$1.1M

Headquarters

San Diego, California

Founded

1989

Growth & Insights
Headcount

6 month growth

7%

1 year growth

0%

2 year growth

7%
Simplify Jobs

Simplify's Take

What believers are saying

  • ResMed aims to reach 500 million breathing health patients by 2030.
  • The integration of AI in devices enhances patient monitoring and therapy personalization.
  • The acquisition of Inhealthcare expands ResMed's capabilities in remote patient monitoring.

What critics are saying

  • Increased competition in the CPAP market may affect ResMed's market share.
  • Challenges in integrating Inhealthcare's technology could lead to operational inefficiencies.

What makes Resmed unique

  • ResMed offers cloud-connected devices for sleep apnea and chronic disease management.
  • The company integrates software platforms to enhance patient care and reduce hospital visits.
  • ResMed operates in over 120 countries, providing a global reach for its solutions.

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