Senior RA Specialist

As a Senior Regulatory Affairs Specialist at Sibel Health, your primary responsibilities will include developing regulatory strategies for product development, preparing and submitting regulatory documents such as 510(k)s, and providing guidance to cross-functional teams to ensure compliance from product conception to launch.

To qualify for the Senior Regulatory Affairs Specialist position at Sibel Health, you should hold a Bachelor's degree in a relevant scientific or engineering discipline and have over three years of experience in regulatory affairs within the medical device industry. A strong understanding of US medical device regulations is essential.

Collaboration is key for the Senior Regulatory Affairs Specialist at Sibel Health. You'll work closely with clinical, QA, and R&D teams to support efforts for regulatory clearance and ensure all documentation is created and maintained in compliance with regulatory standards.

At Sibel Health, the Senior Regulatory Affairs Specialist can expect ample opportunities for growth including enhancing technology skills, leadership development, and mentorship programs. The fast-paced environment encourages learning and collaboration to tackle complex challenges.

Sibel Health offers a range of benefits for the Senior Regulatory Affairs Specialist role including medical, dental, vision, life, and disability insurance, a flexible time-off policy, a Simple IRA plan with employer matching, and yearly stipends for professional development.

In answering this question, it's essential to provide specific examples of submissions you've prepared or managed, detailing the documents you created and how they contributed to successful approvals. Mention any challenges faced and how you overcame them.

Discuss your approach to staying informed about industry regulations, such as subscribing to regulatory newsletters, attending webinars, or participating in professional organizations. Highlight how this knowledge has affected your previous work positively.

Address this question by recounting a specific scenario where teamwork proved essential in achieving a regulatory goal. Emphasize your communication skills, the roles of different team members, and the outcome of your collaborative efforts.

You should outline your project management techniques, such as prioritizing tasks, setting clear timelines, and using tools to keep track of progress and deadlines. Illustrate your answer with an example of a past experience where these strategies led to successful outcomes.

Discuss the types of regulatory documents you've worked with, such as 510(k)s, pre-submission documents, and compliance reports. It might also be helpful to mention any specialty areas you've focused on, such as wearables or pediatric devices.

Detail your approach to receiving and implementing feedback, such as maintaining a constructive attitude and understanding the importance of compliance. Provide an example where feedback led to improved project outcomes.

Research Sibel Health's unique products and their focus on vulnerable populations. Discuss how their mission aligns with your personal values and how you see regulatory affairs enhancing their goals in patient care.

Share a specific example where unexpected challenges required you to pivot your regulatory strategy, outlining your thought process and the eventual results. Highlight the skills that allowed you to navigate these changes.

Explain the critical role of risk management in regulatory processes. Provide insights into how you assess risks associated with products and how this information guides regulatory submissions and compliance decisions.

Articulate your enthusiasm for Sibel Health’s mission and your desire to be part of a team that focuses on innovative healthcare solutions. Connect your professional experience and values with their commitment to improving health data accessibility.