Regulatory Operations Specialist at Invitae (Remote)
Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people! Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry, by making clinical-grade genetic information affordable and accessible to guide health decisions across all stages of life.
Within the Regulatory Operations team, the Regulatory Operations Specialist will help create, implement, and maintain an array of regulatory department documentation and processes. Key areas of focus are streamlining the following processes: regulatory operations and procedures, labeling development, new and changing standards and regulations, and adverse event/vigilance assessment and reporting.
What you’ll do:
- Assist department manager with the development and implementation of regulatory procedures, particularly focused on project documentation for global medical device registration.
- Support project teams with the development, maintenance and review of product labels/labeling, including the requirements of UDI and EUDAMED.
- Coordinate translation of label/labeling with approved vendors.
- Support the process to track product renewals and/or re-registration dates to ensure products remain in compliance with the appropriate country registrations.
- Support the New and Changing Standards and Regulations process (NCSR), particularly as it relates to changes in global label/labeling requirements.
- Conduct timely assessments of complaints for adverse event/vigilance reporting.
- Perform other duties as assigned by supervisor, including case-by-case general compliance matters.
What you bring:
- Minimum B.S./B.A. or equivalent experience (2-5 years)
- Experience with ISO 13485:2016 and 21CFR820 quality systems within regulated medical device space
- Knowledge of medical device labeling standards such as ISO 28219, ISO 15223, and ISO 17100
- High degree of proficiency with MS Office and Adobe PDF creation.
- Meticulous attention to detail and a sense of aesthetics
- HTML and content management systems knowledge
- Experience with Bartender labeling software a plus.
- Proficiency in core Adobe Creative Suite design products: Photoshop, Illustrator, InDesign, or similar
Please apply even if you don’t meet all of the “What you bring” requirements noted. It’s rare that someone checks every single item, it’s ok, we encourage you to apply anyways.
In Colorado, our competitive compensation package includes a base salary starting from $71,360.00. In determining the final salary offered, we will evaluate a specific candidate’s geographic location, education, skills, and experience.
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
We truly believe a diverse workplace is crucial to our company's success and to better serve our diverse patients. Your input is especially valuable. We’d greatly appreciate it if you can take a quick moment to make your selection(s) below. Submissions will be anonymous.