Senior Regulatory Affairs Specialist

A Senior Regulatory Affairs Specialist at Lexington Medical is responsible for developing and implementing regulatory strategies for both new and existing products. This includes preparing amendments, new device applications, and 510(k) submissions, as well as maintaining compliance with global regulations like EU MDR and MDSAP. The specialist leads regulatory efforts, ensures compliance in product labeling and promotional materials, and interacts with regulatory agencies to facilitate approvals.

To qualify for the Senior Regulatory Affairs Specialist role at Lexington Medical, candidates need a Bachelor's degree in a relevant field such as Science, Engineering, or Regulatory Affairs, along with 5-8+ years of experience in medical device regulatory affairs. Proficiency with 510(k) submissions, EU MDR, and knowledge of international standards like MDSAP and ISO 13485 are essential. Strong communication and strategic thinking skills are also important.

At Lexington Medical, a Senior Regulatory Affairs Specialist plays a vital role in product development by serving as the regulatory voice on cross-functional teams. They collaborate with engineers and commercial teams to ensure that regulatory requirements are accurately integrated into the product lifecycle, helping to ensure that products are safe, effective, and compliant with all regulatory standards.

Experience with international regulations, including MDSAP, EU MDR, and ISO 13485, is highly beneficial for the Senior Regulatory Affairs Specialist role at Lexington Medical. Such knowledge allows the specialist to navigate various regulatory environments effectively, ensuring compliance and facilitating product approvals across different jurisdictions.

A Senior Regulatory Affairs Specialist at Lexington Medical will manage multiple projects simultaneously, including preparing regulatory submissions, conducting compliance assessments for new products, and leading efforts to align with evolving international standards. The role demands meticulous attention to detail and strategic planning to meet project deadlines and regulatory requirements.

In answering this question, highlight specific examples of 510(k) submissions you've handled, outlining your role in preparing documentation, conducting necessary research, and collaborating with relevant teams to ensure compliance and successful submission.

Discuss various resources you use to stay informed about regulatory changes, such as industry publications, webinars, and professional organizations related to regulatory affairs. Emphasize your proactive approach in continuously enhancing your knowledge and skills.

Share your time management techniques, use of project management tools, and how you prioritize tasks based on deadlines and regulatory impact. Giving specific examples will showcase your organizational skills and ability to multitask effectively.

Explain how you would respond by first assessing the concerns raised, gathering relevant documentation, and working with cross-functional teams to address and rectify any issues. Demonstrating a solution-oriented mindset and effective communication is key.

Articulate your understanding of the EU MDR regulation by discussing its significant elements and how you've implemented these in your previous roles. Mention specific projects or examples where compliance was pivotal.

When responding to this question, provide an example of a past conflict, detailing how you communicated openly with team members to find a resolution while focusing on achieving a common goal, thus illustrating your collaboration skills.

Share a specific instance where your data-driven approach helped persuade stakeholders to accept your recommendations. Highlight the communication techniques you used to present your case effectively.

Emphasize the critical nature of attention to detail in regulatory affairs, illustrating how it directly impacts product safety, compliance, and approval success. Mention concrete examples of how you ensure precision in documentation.

Discuss specific challenges, such as navigating a complex regulatory landscape or addressing non-compliance issues. Describe your problem-solving strategies and the results that followed.

Illustrate your collaborative approach by discussing regular meetings, shared objectives, and documentation that facilitate open communication. Highlight your role in guiding the team through the regulatory implications of product decisions.