The Regulatory Affairs SaMD Specialist 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 software products.
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 accommodate partial 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 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.
Qualifications and Experience
- Bachelor's degree (technical or software background preferred) from four-year college or university; in addition to 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
- Equivalent combination of experience and/or education may be considered
This role is eligible for a Sales Incentive Plan with a target of $65,000 annually.
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 base range for this position is: $95,000 - $142,000
?For remote positions located outside of the US, pay will be determined based the candidate’s geographic work location, relevant qualifications, work experience, and skills.
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!