Sr. Regulatory Affairs Specialist - Recall and Post Market Compliance (Remote)

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.Sr. Specialist within Regulatory Affairs (RA) will be an instrumental member of the Regulatory Affairs team supporting on-market IVD product within the U.S. and internationally. This role will support regulatory compliance with regard to recalls, field actions, adverse events, and Post-Market Surveillance. Responsibilities will include interacting with various corporate functions and provide regulatory guidance as needed. Write and implement regulatory procedures for continuous improvement.  Additionally, you will be responsible for ensuring timely and effective assessments of new adverse events and field actions to determine if reportability is required.Responsibilities: Represents the RA function on assigned cross-functional project teamsInterprets and applies regulations by creating regulatory strategies for domestic and international marketsDevelops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizationsPrepares hardcopy and electronic information packages for submission to regulatory agenciesProvides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory complianceReviews validation, clinical and stability protocols and reports for regulatory submission soundnessAssesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulationsDefines, monitors and receives deliverables for submissionsWrites and/or edits submission documents using regulatory templates, or creates new templatesAssembles paper and/or electronic copies for submissionMonitors new and revised regulatory requirements; disseminates information as directed by managementInteracts with regulatory agencies and third party accrediting bodiesPrepares internal procedures for continuous process improvementMentors junior members of the departmentProvides regulatory guidance and/or training to external departments and partnersAssists with resource planning and budgeting as neededListed 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 experiencePreferred Experiential Background:5+ years experience in Regulatory AffairsExperience with an in vitro diagnostics device company preferred; pharmaceutical, biologics or medical device companies as alternativeStrong understanding of FDA regulations required; other international requirements - EU, Canada, Australia, Japan and China - preferredDemonstrated ability to work independently with new, complex technologies and produce professional work productsStrong written and verbal communication skillsTeam leadership skills preferredFamiliarity and ability to work with office automation programs and corporate database toolsStrong work ethic and demonstrated ability to deliver assignments on time#LI-REMOTEThe estimated base salary range for the Sr. Regulatory Affairs Specialist - Recall and Post Market Compliance (Remote) role based in the United States of America is: $86,500 - $129,700. Should the level or location of the role change during the hiring process, the applicable salary 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. 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