Sr. Regulatory Affairs Specialist- Software at Invitae (Formerly ArcherDx)
Sr. Regulatory Affairs Specialist- Software
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.
Our team is expanding rapidly and we’re looking for people who are passionate about helping improve healthcare to join us.
This position will work with a team of scientists, software engineers, quality and regulatory affairs experts and is responsible for assessing software products for regulatory requirements worldwide. In this role you will provide guidance to development groups and act as the subject matter expert on software regulatory requirements. You will support and lead software regulatory compliance and submission process development and improvements. The candidate needs to be a quick learner to keep up with fast developments at Invitae.
What you will do:
- Assess software products for regulatory requirements worldwide and give guidance to software development teams.
- Work with subject matter experts to compile technical documentation in support of global registrations.
- Act as a subject matter expert on software regulatory requirements, including documentation, validation and verification, cybersecurity.
- Support or lead process development and improvement activities related to software regulatory compliance and submissions.
- Develop and manage US regulatory submissions for software products.
- Other regulatory support tasks as assigned, such as review of promotional/scientific or labeling materials.
Who you are:
- The successful candidate for the position will have a Bachelor’s degree preferably in life sciences, advanced degrees (MS/PhD) are strongly preferred with a minimum of 5 years experience working in Regulatory Affairs relevant to medical device and/ or IVD products, preferably including software products
- Must have experience with technical documentation and will have the ability to read, analyze, and interpret technical documents, professional journals, technical procedures and government regulations.
- Solid understanding of Quality System Regulation (QSR) requirements.
- Expert use of Microsoft Word, Excel, PowerPoint, and experience with document management systems and document sharing systems.
- Problem solving skills, motivation, good judgement, ability to manage multiple tasks.
- Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation, and style.
- Excellent communication and teamwork skills, and the ability to adapt and interface effectively with a wide range of stakeholders.
- Experience with project management and/or process improvement is a plus.
By joining Invitae, you’ll work alongside some of the world’s experts in genetics and healthcare at the forefront of genetic medicine. We’ve created a culture that empowers our teams and our teammates to have the biggest impact and to explore their interests and capabilities. We prize freedom with accountability and offer significant flexibility, along with excellent benefits and competitive compensation in a fast-growing organization.
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.