Regulatory Affairs Manager

<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


<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>

keywords: management,quality assurance,maintenance,prepare,management,teamwork,compliance,quality assurance,experience,knowledge

Full time

Regulatory Affairs

Overview: <p><strong>***Please note, Glaukos compensation ranges were not directly given to LinkedIn and are estimated ranges from similar roles. Glaukos provides competitive industry and functional compensation. Please apply and inquire with your recruiter. ***</strong></p> <p><strong>How will you get here?</strong></p> <br />The&nbsp;<strong>Regulatory Affairs Manager</strong>, based in Burlington, MA will be responsible for the preparation of regulatory submissions (foreign and domestic). And will ensure implementation and maintenance of regulatory filings in compliance with applicable regulations and company internal SOPs.
Responsibilities: <ul> <li>Prepare regulatory submissions to regulatory agencies including periodic written reports</li> <li>Interact with Regulatory Agencies as directed by management.</li> <li>Maintain regulatory records. Maintain updated Regulations and Standards information. Maintain contacts with various regulatory agencies to determine proper regulatory pathways and time-lines.</li> <li>Participate in company training programs that maintain appropriate awareness and compliance with ISO, MDR, MDSAP and CFR requirements.</li> <li>Interact and coordinate with Clinical staff to facilitate clinical studies regulatory compliance.</li> <li>Interact and coordinate with R/D staff to ensure compliance to applicable Design Control requirements and ISO standards</li> <li>Interact with Regulatory Agencies during company inspections.</li> </ul>
Requirements: <ul> <li>Hands-on experience in preparing MDD/MDR Technical documentation with knowledge of clinical evaluation requirements</li> <li>Familiarity with Brexit and new Swiss regulations with some exposure to US regulatory.</li> <li>Knowledge of the MDSAP and EU Quality System requirements</li> <li>Familiarity with ISO standards including ISO13485,14971and IEC 60601</li> <li>Solid experience in regulatory compliance, particularly for EU and MDSAP countries</li> <li>B.A/B.S plus minimum of 5 years of hands-on work experience in Regulatory affairs in the Medical Device area.</li> <li>Experience in Ophthalmology is a plus.</li> </ul>