Sr. Director of Regulatory Affairs, Medical Device Corneal Health

<p class=""p1"">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p>

Burlington, MA

Glaukos

<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4> https://www.glaukos.com/

keywords: leadership,strategy,teamwork,quality assurance,develop,analysis,management,prepare,analysis,quality assurance,negotiate,oversee,develop,planning,performance,teamwork,assist,international,experience,degree

Full time

Overview: <p><strong>Provide Strategic Regulatory Guidance to Management and Inter-disciplinary Project Teams</strong></p> <ul> <li>Serve as lead regulatory representative to provide effective regulatory leadership to project team and clinical development teams for clinical stage products.</li> <li>Strong knowledge of FDA, EU, TGA, cGMP and ISO 13485 requirements to ensure compliance with regulatory requirements for manufacturing, design control and clinical development activities.</li> <li>Develop and implement global regulatory strategies and plans for projects at different phases of development.</li> <li>Provide regulatory review and approve internal documents supporting project team and clinical development activities.</li> <li>Lead and manage the development and preparation regulatory submission documents to support the filing and maintenance of IDE, PMA, 510k, MDR applications, etc.&nbsp; &nbsp;&nbsp;</li> <li>Apply expert strategic and scientific regulatory knowledge of product development to ensure compliance with global filing requirements.</li> <li>Interact and coordinate with project team staff to ensure compliance to applicable Design Control requirements for medical device products.</li> </ul>
Responsibilities: <p><strong>Prepare and File High-Quality Submissions to Regulatory Authorities</strong></p> <ul> <li>Oversee the compilation and preparation of high-quality submissions to regulatory authorities (e.g., briefing books, 510k, IDE, PMA, amendments, supplements, annual reports, etc.) ensuring all regulatory requirements are met.</li> <li>Prepare driver reports for submission deliverables and follow-up with team members, ensuring that all</li> <li>applications are filed in accordance with predetermined timelines.</li> <li>Proactively identify regulatory, quality and technical issues and recommend and/or implement solutions to resolve them.</li> <li>Maintain accurate and timely regulatory records and logs.</li> </ul> <p><strong>Interact and Negotiate with Regulatory Agencies, Primarily US &amp; EU, Regarding Strategy and Resolution of Complex Issues</strong></p> <ul> <li>Manage resolution and responses to queries from regulatory agencies (FDA and OUS).</li> <li>Management of medical device import &amp; export processes.</li> <li>Participate in regulatory meetings with Competent Authorities</li> </ul> <p><strong>Manage and Prioritize Assigned Projects in Accordance with Department and Company Goals</strong></p> <ul> <li>Assist in managing and prioritizing the team's workload in accordance with departmental goals.</li> <li>Ensure that multi-disciplinary project teams work effectively and productively and have proper coordination.</li> <li>Stay Abreast of US &amp; International Regulatory Initiatives; Continually Innovate and Adapt Practices to Ensure Best Practices</li> <li>Stay current on new regulatory or other industry initiatives that could have a significant impact on the company&rsquo;s current or development products.</li> <li>Share best practices for planning, organization and time management.</li> <li>Gain deep insight into the medical device industry by actively participating in professional organizations.</li> <li>Ensure that department management is aware of team activities and progress.</li> <li>Develop staff and conduct quarterly check-in reviews, as applicable.</li> <li>Perform other duties as assigned.</li> </ul>
Requirements: <ul> <li>A Bachelor&rsquo;s Degree (minimum) in a scientific discipline from an accredited university is required.</li> <li>Minimum of 10 years of regulatory or related experience</li> <li>A minimum of 10 years&rsquo; experience in medical device&nbsp; development with 5 years&rsquo; experience in US regulatory development</li> <li>A minimum of 3 years of supervisory experience</li> <li>Hands-on experience in preparing FDA, EU, and OUS premarket submission applications, including but not limited to IDE&rsquo;s, 510 (k)&rsquo;s, PMA, EU MDR&rsquo;s product registration, etc.</li> <li>Solid experience of regulatory system in a FDA regulated environment, including compliance aspects.</li> </ul> <br /> <p><strong>Knowledge, Skills, and Abilities</strong></p> <ul> <li>Team Player, adaptability, hand-on minded, problem solving minded</li> <li>Critical thinking, ability to determine root cause, to generate multiple solutions</li> <li>Well organized, self-motivated and dependable</li> <li>Open to directions and constructive feed-back</li> <li>Willing to be part of a fast growing organization</li> </ul> <p><strong>Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.&nbsp;&nbsp;</strong></p> <p>These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.&nbsp;</p> <p>Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.&nbsp;</p> <p>We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off &amp; paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Check out our profile on The Muse to get an inside look at our company culture. Glaukos Corporation has been Certified as a Great Place to Work the last two years!&nbsp;</p>