Regulatory Affairs Specialist II

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.

As a Regulatory Affairs Specialist II, you will have the opportunity to contribute to a variety of regulatory activities supporting new and on-market IVD products as part of a dynamic and collaborative team.

Responsibilities:

• Support RA team in coordinating, compiling and preparing document packages for submission to regulatory agencies

• Write and/or edit submission documents using regulatory templates

• Review project documentation for regulatory submission soundness

• Independently contribute to multiple projects/teams within the department.

• Assist with design and process change assessments for regulatory reporting impact and compliance

• Monitor new and revised regulatory requirements; disseminate information as directed by management

• Assist in the review of marketing and promotional literature to ensure they can withstand regulatory body scrutiny

• Actively participate as a member of RA teams and cross-functional project teams

• Write and/or edit process documents using RA templates, or create new templates in support of continuous RA process improvement

• Perform other related duties as assigned  

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.

Requirements:

• Demonstrated ability to work independently with new, complex technologies, office automation programs and corporate database tools to produce professional work products

• Must be productive, demonstrate the ability to deal with timeline stress, be able to cope with multiple tasks, and be able to prioritize tasks with the supervisor input

• Excellent written and oral communication skills

• Must be able to gather, write, edit and facilitate assembly of memos, and process product and system information for regulatory purposes

• Strong collaborative and detail-oriented work ethic and demonstrated ability to deliver assignments on time

 

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

 

Experience/Education:

• Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.

The estimated base salary range for the Regulatory Affairs Specialist II role based in the United States of America is: $74,900 - $112,300. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. 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.