Regulatory Affairs Specialist II

A Regulatory Affairs Specialist II at Penumbra, Inc. plays a crucial role in coordinating and preparing regulatory submissions for medical devices. This includes managing complex documents required for approvals such as 510(k) and CE-Mark submissions. You would also be responsible for tracking multiple device projects, maintaining regulatory documentation, and supporting labeling reviews. Engaging with various stakeholders and conducting research on competing products and regulations are also part of your essential duties.

To apply for the Regulatory Affairs Specialist II position at Penumbra, Inc., you should have a bachelor's degree in a science discipline or a related field, along with at least 2 years of experience in regulatory affairs, particularly with medical devices. Strong communication skills, attention to detail, and proficiency in Microsoft Office tools are crucial, along with the ability to effectively apply technical standards and regulations in your work.

Success as a Regulatory Affairs Specialist II at Penumbra, Inc. comes from a combination of skills and mindset. A strong attention to detail is essential, as is the ability to manage multiple projects simultaneously. Effective communication is key when collaborating with cross-functional teams and health authorities, and being proactive in researching regulatory changes can give you an edge. A commitment to understanding and maintaining compliance with Quality System regulations and regional requirements will also contribute greatly to your success.

At Penumbra, Inc., a Regulatory Affairs Specialist II will work in a dynamic office environment where collaboration and teamwork are highly valued. The company fosters a culture of constant learning and rewards performance. You can expect a supportive environment that allows for professional growth and development while working on innovative medical technologies that have a meaningful impact on patient care across the globe.

Penumbra, Inc. offers a competitive benefits package for employees in the Regulatory Affairs Specialist II role, which includes health and dental insurance, a 401(k) plan with employer matching, and an employee stock purchase plan. Additional perks include generous paid vacation days that increase with tenure, paid parental leave, and compliance with all state labor laws for paid sick time. The company believes in a healthy work-life balance, making it a great place to thrive professionally.

In responding to this question, highlight specific regulatory submissions you've managed, such as 510(k) or CE-Mark applications. Discuss your role in the submission processes, any challenges you faced, and how you overcome them. Emphasize your attention to detail and organizational skills while explaining your approach to ensuring compliance with relevant regulatory standards.

Explain your methods for keeping abreast of regulatory changes, such as subscribing to professional journals, attending industry conferences, or participating in webinars. Discuss how you apply this knowledge practically in your work and provide an example of a time when staying informed helped your team navigate a regulatory change successfully.

Discuss your prioritization techniques, such as using project management tools, creating detailed schedules, and setting clear deadlines. Provide a past example where you successfully managed overlapping deadlines, emphasizing your organizational skills and ability to adapt to new information quickly.

Share a specific instance when you worked closely with cross-functional teams, detailing the collaboration processes. Highlight your communication skills, emphasizing how you ensured all stakeholders were informed and that regulatory requirements were met while keeping projects on track.

Articulate the importance of quality control in regulatory affairs by discussing how it ensures compliance with regulations and enhances product safety. You can share examples of how you have integrated quality control measures into regulatory processes, emphasizing compliance with ISO 13485 standards.

Choose a detailed example that illustrates a challenge you faced, such as a delayed submission or unexpected regulatory change. Explain your thought process in addressing the issue, the steps you took to resolve it, and the lessons you learned from the experience.

Discuss specific tools you regularly use for managing regulatory documentation, such as Microsoft Office Suite or dedicated regulatory software. Explain how these tools help you maintain accuracy, organization, and compliance while ensuring that documentation is prepared efficiently.

Describe your approach to gathering and verifying competitive product information and regulatory updates. Discuss specific resources you utilize, including government agencies, industry publications, and networking with other professionals. Emphasize the importance of thorough research in keeping the regulatory team informed and compliant.

In your response, outline the various post-market responsibilities, such as monitoring product performance, reporting adverse events, and maintaining compliance with regulations. Provide examples of any past experience you have had with these activities and how you ensured adherence to regulatory requirements in the post-market phase.

In this question, share your motivation for choosing a career in regulatory affairs and specifically why Penumbra, Inc. stands out. Discuss your admiration for the company’s commitment to innovative therapies and healthcare. Convey your desire to contribute to a mission that aligns with your values and passion for advancing medical technology that improves patient outcomes.