Regulatory Affairs Specialist (PCM) at Invitae (Formerly ArcherDx)
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 Regulatory Affairs Specialist, reporting to the Regulatory Affairs Director, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creation and maintenance of the documentation associated with filing for high risk medical device for US submissions.
- Assist with the development and implementation of regulatory procedures
- Operate as the primary contact for regulatory submissions, including, but not limited to, pre-submission meetings and marketing applications.
- Act as primary author and project representative for FDA IDE, 510(k), PMA submissions and PMA supplements.
- Take on assignments from project core teams and support other initiatives on a departmental basis.
- Maintain marketing authorizations and approvals through change management and, if necessary, drafting and submission of supplements or change notifications to regulatory authorities.
- Review of the documentation associated with the support and continued manufacturing for Companion Diagnostics.
- Perform other duties as assigned by supervisor
- 3+ years of medical device regulatory affairs experience, prefer proven experience as a primary submission owner
- High degree of proficiency with MS Office and Adobe PDF creation.
- Experience writing FDA marketing applications (e.g. PMA, de novo 510(k)) for IVD products, acting as the primary submission author and/or RA core team representative.
- Experience with change control and regulatory impact assessments
- Experience with quality systems in regulated space preferred, with responsibility for generating new documents and conducting team reviews.
- Experience with good manufacturing practice and good document practice
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
- Ability to work independently, and utilize good problem-solving skills
- Ability to multitask and work within a fast-paced dynamic team environment
- Must be hands-on, self-directed, organized and conscientious;
- Demonstrated hands on change management leadership skills;
- Excellent written and verbal communication skills;
- Problem solving prowess in consistently evolving environment;
- Proven ability to work under pressure and with short deadlines to accomplish objectives;
- Ability to communicate effectively with technical and non-technical personnel.
- Bachelor’s degree required;
- Graduate degree in molecular biology, engineering and/or relevant scientific discipline highly desired;
- Knowledge of manufacturing in a regulated environment (ISO 13485, 21CFR820, cGMP) and related manufacturing and process control requirements.
In Colorado, our competitive compensation package includes a base salary starting from $95,000. 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 support
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.