Senior Regulatory Specialist - Covington, GA

As a Senior Regulatory Specialist at BD in Covington, GA, your key responsibilities will include preparing for U.S. and CE marking submissions, with an emphasis on EU/MDR compliance. You'll provide regulatory support throughout the product lifecycle, develop regulatory strategies, handle change controls, and ensure timely submission of technical documents. Additionally, you will guide post-market activities and collaborate with cross-functional teams to facilitate effective regulatory submissions.

To qualify for the Senior Regulatory Specialist role at BD, candidates must possess a BS degree in a scientific field or a regulated industry, along with a minimum of 4 years of regulatory experience in the medical device sector. Knowledge of U.S. and European medical device regulations is crucial, along with the ability to create technical documents and provide regulatory support throughout the product lifecycle. A Regulatory Affairs Certification (RAC) is preferred but not mandatory.

Yes, the Senior Regulatory Specialist role at BD offers a hybrid model, requiring employees to be onsite in Covington, GA, four days a week and allows for remote work on Fridays. This setup provides flexibility while still facilitating collaboration with team members on critical regulatory projects.

The Senior Regulatory Specialist at BD plays a vital role in enhancing patient healthcare by ensuring that all medical devices meet stringent regulatory standards for both the U.S. and international markets. By managing submissions effectively and ensuring compliance with EU/MDR regulations, you contribute directly to the development of safe and effective medical devices that improve patient outcomes in urgent healthcare situations.

Success as a Senior Regulatory Specialist at BD requires strong analytical, technical writing, and communication skills. You should be able to prioritize multiple projects simultaneously, maintain confidentiality, and work independently while being a proactive team player. In-depth knowledge of regulatory requirements for medical devices and the ability to navigate complex submission processes are also critical for this role.

In responding to this question, highlight specific examples of your work with regulatory submissions. Discuss the types of submissions you’ve handled, such as 510(k) and CE marking, and mention your familiarity with relevant regulations. Emphasizing your contributions to timelines and successful submissions will demonstrate your expertise.

To answer this, mention specific resources you rely on, such as regulatory agencies' websites, industry journals, and professional networks. Highlight your commitment to continuous learning and adapting to changes in regulations, which is essential for a Senior Regulatory Specialist at BD.

Talk about your organizational skills and the tools or methods you use for project management. Discuss prioritization techniques and how you ensure deadlines are met while maintaining high-quality submissions.

For this question, share a specific example where you faced a regulatory challenge. Describe the issue, the steps you took to address it, and the outcome. Highlighting your problem-solving skills and ability to work under pressure will resonate well with interviewers.

You can discuss the protocols and practices you follow to maintain confidentiality, such as secure storage of documents, limited access for unauthorized personnel, and adherence to company policies regarding sensitive information.

Emphasize the importance of collaboration in successfully navigating regulatory processes. Discuss how working with cross-functional teams, such as R&D, quality, and marketing, contributes to timely and successful regulatory submissions.

Outline your approach to conflict resolution, which should include open communication and a focus on the issue at hand rather than personal feelings. Emphasize your willingness to listen, provide evidence-based arguments, and seek consensus.

Discuss the importance of understanding the product, market requirements, and regulatory landscape. Describe how you would assess risks, collaborate with project teams, and create a comprehensive regulatory plan that aligns with product development timelines.

Mention specific software or tools you are familiar with for technical writing, such as Microsoft Word for documentation, regulatory databases for compliance tracking, or project management software for collaboration. Emphasize the importance of clear and precise documentation in regulatory affairs.

Share your motivations for wanting to join BD, such as its reputation for innovation, commitment to improving healthcare, and alignment with your professional values. Highlight how your skills and experiences make you a great fit for the role and how you can contribute to the company's success.