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Senior Manager, Regulatory Affairs
hace 5 meses
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 Italy_
The 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.
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.
**Responsibilities**:
- Lead complex regulatory submission teams
- Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance
- Review validation, clinical and stability protocols and reports for regulatory submission soundness
- Assess manufacturing process and labeling changes for regulatory reporting impact
- Define, monitor and receive deliverables for submissions
- Participate in Material Review Board and complaint/recall meetings
- Complete health hazard assessments for regulatory reporting of product problems; prepare regulatory agency information packages
- Keep informed of new and revised regulations; disseminate information as directed by management
- Interact with regulatory agencies, maintain correspondence and other records of interaction
- Prepare internal procedures for continuous process improvement
- Mentor junior members of the department
- Provide regulatory guidance and/or training to external departments and marketing partners
- Assist in hosting inspections, as needed
- Assist in conducting internal/external audits, as needed
- Manage 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 Expect
Our 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-REMOTE
Illumina 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.
