Sr. Regulatory Affairs Specialist, International 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 Senior Regulatory Affairs Specialist will help develop and prepare global regulatory submissions for new products and product changes, implement and maintain regulatory processes within the Quality Management System (QMS), and work with cross functional teams to mitigate or resolve regulatory issues and support responses to questions from regulatory agencies.
- Develop and implement or revise regulatory procedures to reflect regulatory requirements
- Participate in communication with regulatory agencies
- Create and manage filings for IDE, 510(k), PMA and EU Technical Files.
- Own and drive assignments from project core teams to completion and support other initiatives on a departmental basis.
- Evaluate customer complaints to determine if regulatory notification is required.
- Support and/or own regulatory compliance activities, including review or creation of documentation supporting the manufacture of companion diagnostics, GMP audits, post market reporting, etc.
- 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
- Familiarity with regulatory submissions including IDE, 510(k), and PMA for IVD and/or Companion Diagnostics
- 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.
- 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 $129,000. In determining the final salary offered, we will evaluate a specific candidate's 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.