Senior Manager, Regulatory Affairs

Shape the Future of Vision Care with Euclid Vision Corporation!

Are you a regulatory affairs professional with a passion for medical device innovation? Do you thrive in a collaborative, fast-paced environment where your expertise drives global impact? Join Euclid Vision Corporation—a global leader in advanced vision solutions—and help us bring life-changing products to patients worldwide.

Why Euclid Vision Corporation?

At Euclid, we’re dedicated to transforming lives through cutting-edge vision care. Our culture is built on teamwork, integrity, and continuous improvement. We value our people, encourage professional growth, and celebrate success together. 

About The Role

As Senior Manager, Regulatory Affairs, you’ll play a pivotal role in developing and executing global regulatory strategies for our innovative medical devices. You’ll provide expert guidance to cross-functional teams, lead regulatory submissions, and ensure ongoing compliance with international standards. You’ll also mentor regulatory staff and serve as a key liaison with regulatory authorities.

Key Responsibilities:

• Lead and support global device approvals in the US, EU, UK, Australia, Korea, China, Taiwan, Singapore, India, and Japan.
• Develop and implement regulatory processes for timely and accurate device approvals.
• Interpret and communicate regulatory requirements for products, procedures, testing, and record keeping.
• Guide project teams on regulatory filings, testing, and standards throughout the submission process.
• Review and analyze technical data from R&D, Manufacturing, Marketing, Clinical Research, and Quality Assurance for regulatory submissions.
• Evaluate design and manufacturing changes, nonconforming materials, and test protocols to ensure compliance with ISO 13485, 21 CFR 820, UK MDR 2002, EU MDR 2017/745, and other standards.
• Support adverse event reporting, vigilance, and medical device reporting activities.
• Prepare and coordinate global regulatory submissions, including IDEs, PMAs, PMA Supplements, 510(k)s, Technical Files, product and facility registrations, Risk Impact Assessments, and Change Notices.
• Review and advise on labeling, product claims, training materials, publications, and marketing materials for regulatory compliance.
• Advise on global product registration and export approval requirements.
• Serve as a liaison with regulatory authorities and participate in meetings, calls, and presentations.
• Mentor and support the development of regulatory staff.
• Contribute to the improvement of regulatory processes and procedures.

Qualifications:

• Bachelor’s degree in Science, Life Science, Engineering, or related field.
• 5+ years of Regulatory Affairs experience preparing submissions for Class III US and EU medical devices, with a proven track record.
• Strong knowledge of US, European, and global regulatory processes.
• Experience preparing and submitting Pre-IDEs, IDEs, PMA supplements, Technical Files/Documents, and amendments.
• Demonstrated success in obtaining device approvals under EU MDR and UK MDR 2002 preferred.
• Excellent verbal and written communication skills, including experience presenting to regulatory agencies.
• Strong interpersonal, leadership, and mentoring skills.
• Ability to work independently, manage multiple projects, and thrive in a fast-paced, timeline-driven environment.
• Willingness to work a flexible schedule as needed.

What We Offer:

• Competitive compensation and benefits package.
• Opportunities for professional growth and advancement.
• Collaborative, innovative, and supportive work culture.
• The chance to make a global impact in vision care.

Ready to Make a Difference?

If you’re a regulatory affairs expert looking to join a company that values your expertise and supports your career, we want to hear from you! Apply today and help us shape the future of vision care at Euclid Vision Corporation.