Senior Manager, Regulatory Affairs

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.Senior Manager, Regulatory Affairs - REMOTE from one of the following countries: Spain, Belgium, France, Germany, or ItalyThe Senior Manager, Regulatory Affairs at Illumina will work to support CE-certification and registration of products in EMEA countries so that they can be placed on the market in EU/EEA and across EMEA. The role will interact with internal stakeholders, channel partners and regulators in connection with IVD regulations for product certification, registration and notification, as well as vigilance and field actions. You will have the opportunity to support Regulatory Affairs worldwide as you will be part of a Global team and interacting regularly to provide expertise needed. Please note that this is a remote position. It is essential for the role that the successful candidate has fluent/native English language skills. Applications Closing Date: Wednesday 29th May 2024 Illumina's employee benefits are industry-leading and include, flexible time off, private medical insurance, compassion and care time off, leisure travel insurance, pension, employee stock purchasing program, volunteer time off, and much more! Why You:For those that have a scientific background and an understanding of regulatory affairs, this role could be that next big step in your career. Our team has individuals located across the globe working together to ensure our cutting edge products are in line with regulations. You will have an opportunity to work cross functionally with various team member, technical and non-technical, as well as external regulatory bodies. If you are located in one of the aforementioned countries and are ok working remotely, then take a look at the job advert and apply today. Responsibilities:Interpreting and applying regulations by creating regulatory strategies for EU, UK, Switzerland, and emerging markets across AMEALead complex regulatory submission teamsProvide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory complianceReview validation, clinical and stability protocols and reports for regulatory submission soundnessAssess manufacturing process and labeling changes for regulatory reporting impactDefine, monitor and receive deliverables for submissionsParticipate in Material Review Board and complaint/recall meetingsComplete health hazard assessments for regulatory reporting of product problems; prepare regulatory agency information packagesKeep informed of new and revised regulations; disseminate information as directed by managementInteract with regulatory agencies, maintain correspondence and other records of interactionPrepare internal procedures for continuous process improvementMentor junior members of the departmentProvide regulatory guidance and/or training to external departments and marketing partnersAssist in hosting inspections, as neededAssist in conducting internal/external audits, as neededManage consultants, as needed Preferred Requirements:Typically requires a minimum of substantial related experience with a Bachelor’s degree; or extensive experience and a Master’s degree; or a PhD with considerable experience; or equivalent experience.Proven experience with significant experience of practice interacting with regulatory agencies dealing with matters of compliance with ISO, EU and other AMEA regulations and standards.Must be detail oriented, well organized, and able to work independently and in teams.Must have excellent interpersonal skills, as well as verbal and written communication skills. What Can You ExpectOur team members are bright, energetic, and dedicated - they are the driving force behind our innovation and impact. To attract the best and brightest, we offer a competitive employee benefits program. We view it as a smart investment in our people, one that recognizes the tremendous value they bring to our business every day. At Illumina, we push boundaries. We think beyond the conventional. We dream big. With the energy of so many bright and accomplished people, the opportunities are endless.  INDEUR#LI-EMEA#LI-REMOTEIllumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunities 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.