Labeling Specialist (Medical Device)

About BioIntelliSense

BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM) and Screening (COVID-19/Infection). Our medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multi-parameter vital signs, physiological biometrics, and symptomatic events through an effortless patient experience. The FDA-cleared BioSticker™ and BioButton™ devices make remote monitoring and early detection simple. Through the platform’s advanced analytics, clinicians, patients, and employers will now have access to high-resolution patient trending and reporting to enable medical grade care at home, and medical grade screening in the office, school, or residence. For more information on how BioIntelliSense is redefining remote patient monitoring through medical-grade and cost-effective data services, please visit our website at BioIntelliSense.com.

About The Role

As a Labeling Specialist, you will create, update, and maintain labeling components for highly technical and innovative medical devices. This position will interact with other departments to assure labeling follows regulations (FDA 21 CFR 820, ISO 13485, etc.).

Activities include:

• Research and interpret labeling regulations, standards, and guidance
• Work with cross-functional stakeholders to create labeling requirements and specifications.
• Develop and write labelling content for current and new product introductions.
• Assist in providing labeling guidance and actively participate/collaborate with cross-functional teams
• Coordinate outsourced labeling activities such as translations or visual design.
• Execute ECOs as needed for labeling release
• Assists in continuous improvement to labeling process.
• Collaborate with cross-functional product development teams to acquire source material and information to develop understanding of the products.
• Work with complex labeling-related projects including maintaining schedules, understanding inter-dependencies, and providing labeling deliverables.

What We Are Looking For

• Bachelor’s degree in a scientific or engineering discipline
• Minimum 2+ years medical device labeling experience
• Healthcare or medical device start-up experience is preferred
• Polished verbal and written communication skills
• Highly organized and attentive to details

Job Type: Full-time – Exempt

Salary Expectations: $60-80K total compensation (based on experience and location)

Work Location: Golden, CO, Redwood City, CA or Remote will be considered

You're excited about this opportunity because you will…

• Join a fast-growing company and grow right along with us.
• Work on challenging and interesting tech problems which reshapes the future of healthcare.
• Get the chance to work on cutting-edge technologies and use world-class tooling to get the job done.
• Make a large impact across the company through business deliverables and continuous innovation.
• Opportunity to build solutions and organizations from 0 to 1.

Why You'll Love Working at BioIntelliSense

• We are leaders - Leadership is not limited to our management team. It's something everyone at BioIntelliSense embraces and embodies.
• We are doers - We believe the only way to predict the future is to build it. Creating solutions that will lead BioIntelliSense and healthcare industry is what we do - on every project, every day.
• We are learning - We're not afraid to dig in and uncover the truth, even if it's scary or inconvenient. Everyone here is continually learning on the job, no matter if we've been in a role for one year or one minute.
• We have great benefits - Medical/Dental/Vision/Life (at little to no cost to the employee), Disability (STD & LTD), 401(k) matching, 10 Paid holidays per year, generous vacation paid time off

**BioIntelliSense is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran, disability status or any other status protected under federal, state or local law.