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Compliance & Regulatory Specialist

Draper, UT (Hybrid)

Who we are

SeekWell is the parent company of 1-800 Contacts, Luna, and Hello Eyes. Our goal is to make it simpler, easier, and more accessible for people to get the vision care they need. We maintain the legendary, award-winning culture 1-800 Contacts started almost 30 years ago and continue to develop innovative, pioneering products and businesses that make consumers cheer and optometrists squirm. We’re owned by KKR – one of the world’s largest and most successful private equity investment companies. We’ve built an excellent company and changed an industry by putting the customer first, always. The best is yet to come!

Things you will do:

In this role, you will take ownership of regulatory compliance, collaborating with cross-functional teams to ensure our products adhere to healthcare and information security regulations. You’ll be responsible for implementing, maintaining, and continuously improving our quality management systems, overseeing compliance processes, and providing expert guidance on regulatory best practices.

Reporting to our Privacy and Compliance Officer, you will play a key role in ensuring our products meet ISO 13485, ISO 27001/2, and FDA QMS standards while successfully navigating the FDA submission process.

The experience we're looking for:

  • 5+ years of experience in regulatory compliance and quality assurance for healthcare devices or medical technology.
  • Strong knowledge of ISO 13485, ISO 27001/2, FDA QMS, and regulatory submission processes.
  • Hands-on experience with FDA submissions and audits.
  • Ability to translate complex regulations into actionable compliance strategies.
  • Excellent problem-solving and communication skills to guide teams through regulatory requirements.
  • Experience with risk management and information security best practices is a plus.

On a regular basis you will:

  • Ensure compliance with ISO 13485 (Medical Device QMS) and ISO 27001/2 (Information Security Management) standards.
  • Develop and maintain FDA-compliant Quality Management System (QMS) processes and documentation.
  • Support and potentially lead and manage FDA regulatory submissions, ensuring timely and accurate filings.
  • Collaborate with product, engineering, and security teams to integrate compliance into product development.
  • Provide expert guidance on regulatory and compliance-related inquiries.
  • Conduct internal audits, risk assessments, and gap analyses to maintain and improve compliance.
  • Stay updated on regulatory changes and proactively implement necessary updates to policies and procedures.
  • Work with external regulatory bodies, auditors, and certification agencies as needed.

Work Environment

  • Work full time in a flexible, hybrid environment, combining remote work with time in our Draper, UT office
  • Collaborative workspace designed to support various working styles

Perks

  • Free eye exams for your entire family
  • Deep discounts on lenses, glasses, and other services
  • Amazing healthcare coverage
  • 401(k) match
  • Flexible PTO
  • Tuition reimbursement program
  • In-house restaurant with highly discounted meals (Steak dinner under $6)
  • Free snacks, ice cream, and drinks every day
  • Full onsite gym

 

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

 #LI-Hybrid

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Beginner: You have basic knowledge of ISO 13485 but limited direct experience implementing or managing compliance processes.

Intermediate: You have experience working with ISO 13485 but may require guidance in managing full compliance programs or leading audits.

Advanced: You have hands-on experience with ISO 13485, ensuring compliance in a healthcare or medical device environment. You are familiar with internal audits and regulatory documentation.

Expert: You have extensive experience implementing and maintaining ISO 13485-compliant QMS processes. You have led internal audits, managed regulatory submissions, and trained teams on compliance best practices.

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Beginner: You have basic knowledge of FDA regulatory submissions but have not yet been directly involved in filing them.

Intermediate: You have some experience supporting FDA submissions but may require guidance in leading a full regulatory process.

Advanced: You have participated in FDA submissions and have a strong understanding of the process, documentation requirements, and regulatory expectations.

Expert: You have successfully led multiple FDA regulatory submissions, ensuring compliance with QMS requirements and working directly with regulatory agencies.

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Expert: You have implemented and managed ISO 27001/2-compliant security programs, conducted risk assessments, and ensured continuous compliance.

Advanced: You have worked with ISO 27001/2 standards, assisting with audits, risk assessments, and security best practices.

Intermediate: You have knowledge of ISO 27001/2 but limited hands-on experience in managing compliance efforts.

Beginner: You have basic awareness of ISO 27001/2 but no direct experience with compliance or security audits.

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Expert: You have led multiple internal audits, conducted risk assessments, and developed compliance improvement strategies.

Advanced: You have experience conducting internal audits and risk assessments, identifying gaps, and working on mitigation strategies.

Intermediate: You have participated in internal audits but may require guidance in leading audit processes or risk assessments.

Beginner: You have limited or no experience with internal audits or formal risk assessments.

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