The Regulatory Affairs SaMDSpecialist is responsible for obtaining domestic and international market access for our innovative software products, including both software as a medical device (SaMD) and non-medical softwareproducts.

 This is achieved by executing regulatory strategies for agency submission and working collaboratively with Global Product Development, Data Science, Product Management, Regulatory, Quality and Commercial teams.  This role reports to the Director, Global Product Regulatory Affairs.

This is a remote role but requires the candidate to accommodatepartial APAC working hours due to working with our global teams. (West Coast hours preferred)

Responsibilities and Accountabilities

• Execute regulatory strategies and provide regulatory guidance and support for commercial launch and throughout the total product lifecycle forboth software as a medical device (SaMD) and non-medical software products.

• Participate in Digital ProviderProduct 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 onprocesses related to software and AI/ML-enabledproducts.

• 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.

Qualifications and Experience

• 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 .

We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance. 
 
Employees accrue fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members. 
Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills. 

At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  A reasonable estimate of the current range for this position is: $85,000.00 - $129,000.00 USD Annual.