Post-Market Surveillance Sr Analyst

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.Position Summary:In accordance with Illumina’s Quality Management System the Post Market Surveillance Analyst will be responsible for leading consolidated data reviews, identification and assignment of actions, and documentation of output from post-market surveillance meetings for specified Illumina products.   The position will support regulatory compliance to U.S. and international regulations.Key Responsibilities:•Fulfill the role of post-market surveillance product owner for specified Illumina products.•Consultation with product development core teams on the creation of post-market surveillance plans for specified Illumina products.•Organize and lead post market surveillance data reviews after commercial product release with cross functional teams comprised of Quality, Medical Affairs, Regulatory Affairs, Product Marketing and other key stakeholders as required.•Coordinate analyses of post-market data with assigned data stream owners in the organization.•Identification of key follow up activities from post market data review and assignment of follow up actions to the appropriate staff or teams.•Documentation and routing of post-market surveillance meeting output in accordance with Illumina’s QMS procedures.•Participate in regulatory audits/internal audits and inspections as appropriate to represent and defend the post-market surveillance plans and output for specified products.•Other projects and responsibilities as assigned.•Support systems and data streams for the receipt and recording of Customer Complaints.•Support the evaluation of complaints through responsible Quality and Regulatory department/divisions.•Support preparation for and representation of the Department for internal/external regulatory audits.•Proactively identify system and process improvement to ensure the department maintains current regulations with a high degree of efficiency.Skills & Capabilities:•Strong ability to derive data from enterprise systems, data analysis and trending skillsets.•Strong Illumina internal network or demonstrated ability to build strong internal networks.•Strong analytical, project management skills, and presentation skills.          •Effective verbal and written communication in individual and group settings.•Must be detail oriented, have good organizational skills and be able to meet deadlines.Min Knowledge & Experience required for the position:•Requires a Bachelor degree, preferably in biology, molecular biology, science or regulatory related areas.•Minimum of 5 years’ experience in the medical device industry (in vitro diagnostics a plus).•Good working understanding of Illumina technology.•General understanding of the molecular diagnostics market in Oncology, Reproductive Health, Genetic Health.•Experience with Post Market Surveillance Requirements.•Familiarity with FDA 21 CFR 820, ISO standards, IVD Directive/Regulation and ISO 13485.•Language fluency: English, with additional languages a plus.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.The estimated base salary range for the Post-Market Surveillance Sr Analyst role based in the United States of America is: $79,300 - $118,900. 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. 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