Manager - IVD Regulatory Operations at Invitae
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 genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.
The Manager, IVD Regulatory Operations will be responsible for managing global regulatory compliance of Invitae’s IVDs and companion diagnostics. The position will create and execute operational strategies that support commercial expansion and enable continued compliance. For globally marketed products, this position will oversee ongoing complaint and vigilance reporting to health authorities around the world, including the USA.
- Assist with the development and implementation of regulatory procedures, particularly focused on proper documentation for medical device registration both outside and within the USA.
- Create draft planning documents to guide project teams on regulatory documentation requirements for a given region or country.
- Provide or arrange for training and informational materials to help Archer project teams with successful foreign registration.
- Identify and manage external partners such as authorized representatives, in-country agents, translation services, CROs and regulatory consultants.
- Lead the development and maintenance of product labeling, including the requirements of UDI and EUDAMED.
- Maintain the process to track product renewal and/or re-registration dates to ensure products remain in compliance with the appropriate country requirements.
- Maintain and monitor the New or Changing Standards or Regulations process (NCSR) and ensure involvement of the appropriate cross-functional groups.
- Ensure Invitae's compliance to post-market requirements, such as complaint reporting, in regions where Invitae sells regulated IVD products.
- Represent Invitae at regulatory meetings in-person, abroad and remotely, and interact with pharmaceutical and foreign regulatory partners as needed.
- Assist in the hosting of audits by regulatory authorities.
- Develop and manage an international regulatory affairs team along with a high functioning post-market vigilance team which partners with other cross-functional representatives.
- Perform other duties as assigned by supervisor, including case-by-case general compliance matters.
- Six or more years of experience in generating submissions, technical files, or other documentation in support of medical device/IVD registration globally.
- Three or more years building and supervising a successful regulatory team.
- Previous regulatory affairs operations experience preferred.
- Strong regulatory strategic thinker with the skills to present resourcing, timeline and tradeoff scenarios to company leadership regarding global deployment of regulated products.
- High degree of proficiency with MS Office and Adobe PDF creation.
- Preference for candidates with language skills beyond English.
- Familiarity with medical device and/or IVD design control processes
- Experience with good manufacturing practice and good document practice.
- Experience with quality systems in regulated space preferred, with responsibility for generating new documents and conducting team reviews.
- Fine research skills with a knack for sketching out solutions to novel issues
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
- Ability to work independently, and report progress efficiently.
- Ability to multitask and work within a fast-paced dynamic team environment
- Minimum B.S./B.A, preferably in a technical field.
In Colorado, our competitive compensation package includes a base salary starting from $129,000. In determining the final salary offered we will evaluate a specific candidate geographic location, education, skills and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
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.