What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
The Senior Regulatory Affairs Specialist will be an instrumental member of the Regulatory Affairs team supporting on-market in vitro diagnostic (IVD) products in the United States and international markets. This role is responsible for supporting post-market regulatory compliance activities, including adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments. The individual will serve as a key regulatory partner to cross-functional teams, providing guidance on regulatory requirements, risk evaluations, and reporting obligations.
Key responsibilities include conducting timely assessments of potential adverse events and field actions to determine regulatory reportability, supporting MDR and recall decision-making, coordinating regulatory reporting activities, developing regulatory justifications and documentation, and ensuring compliance with applicable global regulations. The role will also contribute to continuous improvement initiatives through the development and implementation of regulatory procedures, work instructions, and best practices that strengthen post-market compliance and regulatory oversight.
Responsibilities:
- Represents the RA function on assigned cross-functional project teams
- Interprets and applies regulations by creating regulatory strategies for domestic and international markets
- Develops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizations
- Prepares hardcopy and electronic information packages for submission to regulatory agencies
- Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance
- Reviews validation, clinical and stability protocols and reports for regulatory submission soundness
- Assesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulations
- Defines, monitors and receives deliverables for submissions
- Writes and/or edits submission documents using regulatory templates, or creates new templates
- Assembles paper and/or electronic copies for submission
- Monitors new and revised regulatory requirements; disseminates information as directed by management
- Interacts with regulatory agencies and third party accrediting bodies
- Prepares internal procedures for continuous process improvement
- Provides regulatory guidance and/or training to external departments and partners
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Experience/Education: - Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience
Preferred Experiential Background:
- 5+ years experience in Regulatory Affairs
- Experience with an in vitro diagnostics device company preferred; pharmaceutical, biologics or medical device companies as alternative
- Strong understanding of FDA regulations required; other international requirements - EU, Canada, Australia, Japan and China - preferred
- Demonstrated ability to work independently with new, complex technologies and produce professional work products
- Strong written and verbal communication skills
- Team leadership skills preferred
- Familiarity and ability to work with office automation programs and corporate database tools
- Strong work ethic and demonstrated ability to deliver assignments on time
#LI-REMOTE
The estimated base salary range for the Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote) role based in the United States of America is: $90,000 - $135,000. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long‑term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
