Staff Regulatory Affairs Specialist

The Staff Regulatory Affairs Specialist at iRhythm plays a crucial role in developing regulatory strategies for medical devices, such as SaMD and wearable patches. Responsibilities include preparing international submissions like 510(k) and Q-submissions, interacting with regulatory bodies to facilitate approvals, and leading cross-functional teams in regulatory guidance. This position demands proactive problem-solving and exceptional organizational skills to navigate and address any regulatory hurdles.

To qualify for the Staff Regulatory Affairs Specialist position at iRhythm, candidates should possess 8-10 years of relevant regulatory experience, specifically in medical devices. A Bachelor’s degree is essential, while a Master’s degree is preferred. Notable expertise includes experience with 510(k) submissions, familiarity with global medical device regulations, and preferably hands-on knowledge of AI/ML technologies in healthcare.

At iRhythm, the growth of a Staff Regulatory Affairs Specialist is of paramount importance. The company provides continuous learning opportunities through resources like LinkedIn Learning classes and a supportive team atmosphere that encourages open collaboration. Additionally, employees benefit from a structured review of their contributions, paving the way for professional development and advancement opportunities within the organization.

The work environment for a Staff Regulatory Affairs Specialist at iRhythm is fast-paced and highly collaborative. You will engage regularly with cross-functional teams, where communication and problem-solving are key. With remote work flexibility, you'll find support from your colleagues, as everyone at iRhythm is dedicated to maintaining a culture of inclusivity and a shared mission of improving patient outcomes.

iRhythm provides a comprehensive benefits package for its Staff Regulatory Affairs Specialists that includes competitive compensation, medical, dental, and vision insurance starting on day one, employer contributions to health savings accounts, vacation time, paid parental leave, and much more. Additional perks include a robust 401(k) match, emotional health support services, educational resources, and an Employee Stock Purchase Plan.

When asked about your experience with 510(k) submissions, detail specific instances where you've led or authored such submissions. Highlight your familiarity with the documentation process, timelines, and any interactions with regulatory agencies. Use quantifiable outcomes to showcase your success, like speeding up approval times or successfully resolving unexpected challenges.

In response to how you stay updated on regulations, mention your strategies such as attending industry conferences, subscribing to relevant newsletters, participating in professional organizations, and engaging in continuous education. Sharing how you apply this knowledge in your role will also demonstrate your proactive approach to compliance.

When discussing your familiarity with global medical device regulations, outline your experience with various regulatory frameworks such as 21 CFR 820, EU MDR, and ISO standards. Provide examples of past projects where you navigated these regulations, emphasizing problem-solving and successful outcomes.

For leading cross-functional teams, discuss your approach to fostering collaboration, setting clear goals, and maintaining open communication. Illustrate your answer with examples of how you have coordinated efforts across diverse teams to achieve regulatory milestones while resolving conflicts and aligning priorities.

Explore your method for anticipating regulatory obstacles by sharing your detailed planning practices and risk assessments during development. In your response, demonstrate critical thinking by citing real scenarios where foreseeing potential issues allowed your team to pivot strategies effectively.

When addressing collaboration with regulatory authorities, provide a specific event where you successfully engaged them, whether it be for a submission, query answer, or during reviews. Highlight your communication skills and how you built a constructive relationship that supported the project’s success.

Discuss how essential documentation is to regulatory affairs. Emphasize your attention to detail in maintaining accurate records, creating SOPs, and preparing submissions—stressing that proper documentation not only supports compliance but is also pivotal for audits and future product revisions.

Describe your proactive approach to monitoring changes in regulations and how you implement necessary adjustments to ensure compliance. Provide examples of how you successfully communicated these changes to teams and adapted strategies to meet new requirements, further showcasing your agility.

Mention the software tools you’re familiar with that assist in regulatory processes, such as document management systems or regulatory submission applications. Discuss how these tools improve workflow efficiency and compliance tracking, and if applicable, relate any experiences optimizing their use.

In your response, express your enthusiasm for the unique mission of iRhythm, emphasizing how your skills align with their innovative focus on improving patient care. Share personal motivations, such as the desire to contribute to meaningful advancements in healthcare technology, and how you see yourself growing within the team.