ABOUT MAXTEC

Maxtec specializes in oxygen sensors and analyzers: these products are the core of the company. We are a worldwide leader in the manufacturing of oxygen sensing, delivery and analysis equipment.

As Maxtec branches out to develop new products, we are committed to staying true to our principle that oxygen needs to be accurately measured. Our goal is to continuously produce better methods to measure oxygen and to protect patients.

WORKING AT MAXTEC

At Maxtec, we believe everyone should have the opportunity to create positive change in the world. Through the work we do everyday, we empower healthcare professionals around the world.

Each member of our team brings their own personality, background, and experiences, but united by our common mission, we are one. We don’t let office politics distract us from our goal; we inspire one another to be the best we can be. Maxtec is an environment where creativity is valued and challenges are seen as opportunities to grow.

We are looking for a Regulatory Affairs Specialist to join our team. Responsibilities will include worldwide product registrations and support of regulatory activities, coordination of technical information, and preparation of submissions for device licenses to various governmental regulatory agencies.

• Maintaining existing FDA, Health Canada, CE, and other international licenses, registrations, and documentation (i.e. DHF, Technical Files, STED Files).
• Developing and submitting pre-market approval documentation (i.e. FDA 510k, EU CE Mark, Canada Medical Device License, etc.)
• Serving as RA Representative on project teams with members of development to communicate regulatory and submission requirements.
• Reviewing labeling and other device specific documentation.
• Preparing and submitting import/export documentation.
• Participating in internal and external audits.
• Performing new/changed product assessments.
• Performing document change order reviews, CAPA reviews, Complaint reviews, Hazards Analysis reviews, Phase reviews, etc.
• Assisting the Director of QA/RA in other responsibilities related to the quality management system, including but are not limited to:
  • Assuring compliance to medical regulatory and quality system requirements (i.e. FDA 21 CFR Part 820, MDD, ISO 13485:2016, MDSAP, etc.)
  • Obtaining product certifications (i.e. UL, ETL) from Nationally Recognized Testing Laboratories (NRTL).

REQUIRED:

• 2 years minimum experience in regulated industry (FDA 820 and ISO 13485 preferred)
• Demonstrated proficiency in technical writing
• Demonstrated proficiency with Microsoft Word and Excel

DESIRED:

• B.A./B.S. or Associates plus 2 years related experience
• Experience with manufacturing, product development, or engineering
• Excellent problem-solving skills
• Excellent interpersonal communication skills
• Excellent time-management skills

BENEFITS OF WORKING HERE

• Maxtec is a growing company with new and exciting opportunities
• Team atmosphere where people are passionate about what they do
• Health, Dental, Life and short term and long term disability
• 401K matching
• Paid vacations and Holidays