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Posted Date
3/03/2025
Description
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 Sr. Regulatory Affairs Specialist will be involved in projects that require obtaining agency approvals for both new and existing products. This role requires experience in securing certifications from agencies such as the FCC, CE, EMC/RED, IC, and safety organizations. Familiarity with relevant standards and directives from UL, CSA, FCC, IEC, and EN is essential. Additionally, experience with environmental regulations such as RoHS, WEEE, REACH, and Proposition 65 is a valuable asset. The RA Specialist will create and execute a compliance test plan addressing EMC, EMI, safety, environmental, and other product compliance requirements. 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 Mentors junior members of the department Provides regulatory guidance and/or training to external departments and partners Assists with resource planning and budgeting as needed 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. The estimated base salary range for the Sr. Regulatory Affairs Specialist role based in the United States of America is: $88,200 - $132,400. 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. At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and 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 demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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. 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. The potential of genomics to change the world is unparalleled. At Illumina, we are leading the way. Our technology empowers researchers and clinicians globally to improve cancer treatments, change the course of diseases, protect the environment, and fight food insecurity. We are made up of dedicated professionals, all-in on creating a better world – and we need every skill set on our path to making genomics useful for all. Learn more about life at Illumina.
Salary88,200.00 - 132,400.00 Annual