Full-Time

Regulatory Affairs Samd Specialist

Confirmed live in the last 24 hours

Resmed

Resmed

5,001-10,000 employees

Develops cloud-connected medical devices for chronic diseases

Enterprise Software
Healthcare

Compensation Overview

$85k - $129kAnnually

Mid, Senior

Remote in USA

Remote role but requires accommodation of partial APAC working hours.

Category
Risk & Compliance
Legal & Compliance
Required Skills
Data Science
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 designed to 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. What sets ResMed apart from its competitors is its focus on reducing hospital visits and healthcare costs while improving the quality of life for patients. The company's goal is to enhance patient care and support healthcare professionals and caregivers in managing chronic diseases effectively.

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's acquisition of Inhealthcare enhances its digital health platform for remote monitoring.
  • The global telehealth market growth offers expansion opportunities for ResMed's cloud solutions.
  • Increasing sleep apnea prevalence boosts demand for ResMed's CPAP devices.

What critics are saying

  • Emerging competitors in sleep apnea management could impact ResMed's market share.
  • Rapid telehealth advancements may outpace ResMed's current technological offerings.
  • Regulatory scrutiny on data privacy could increase compliance costs for ResMed.

What makes Resmed unique

  • ResMed's cloud-connected devices offer personalized treatment settings for chronic disease management.
  • The company operates in over 120 countries, providing a global healthcare solution.
  • ResMed's focus on sustainability aligns with rising demand for eco-friendly healthcare solutions.

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