Regulatory Affairs Manager, EMEA
Regulatory Affairs Manager, EMEA
In vitro Diagnostics
Cambridge, UK with possibility for remote working in the EU
Fantastic remuneration package to include company equity, annual bonus scheme, 10% pension, private healthcare and more
Illumina is the driving force in bringing the power of genomics into human healthcare and we are looking for Regulatory Affairs Manager to help pave the way for a whole suit of diagnostic products for the EU markets. This is your opportunity to work in the cutting-edge industry of next generation sequencing and be a key contributor to Illumina’s mission in the EMEA region.
All About You
The incumbent with be expected to provide regulatory support for medical device (research use only, investigational and IVD) product development and core teams. You would be expected to work with the regulatory agencies in EMEA and third party accreditation bodies, such as Illumina’s EU IVD medical device Notified Body, to positively position Illumina’s current and future portfolio and ensure its compliance to current and future regulatory requirements. You would also take a lead on providing support for the activities conducted by the Regulatory Affairs Department, particularly the Illumina Cambridge European Authorised Representative (AR) for Illumina IVD medical devices placed into service in the EU.
- Work with other RA team members to maintain the Illumina Cambridge AR
- Interact with regulatory agencies and third party accrediting bodies, particularly in countries for which you are the nominated lead
- Actively participate as a member of RA teams and cross-functional project teams
- Gather, document and maintain regulatory “intelligence information” for pre-market and post market requirements in EU and the wider EMEA region. Monitor new and revised regulatory requirements and disseminate information to affected parties
- Lead Regulatory Information Review sessions and manage timely and effective assessments of new regulatory information which may impact Illumina
- Assist in the review of marketing and promotional literature to ensure they can withstand regulatory scrutiny
- Support RA team in compiling and preparing hardcopy and electronic information packages for submission to regulatory agencies
- Define, monitor and receive deliverables for submissions
- Write and/or edit process documents using RA templates, or create new templates in support of continuous RA process improvement
- A Bachelor’s degree with proven experience in a regulated sector relevant to Illumina’s core IVD businesses, such as Oncology, Reproductive and Genetic Health or Companion Diagnostics. Completing graduate level courses in the field of Regulatory Affairs would be a plus;
- Demonstrated ability to work independently with new, complex technologies, office automation programs and corporate database tools to produce professional work products;
- Must be productive, demonstrate the ability to deal with timeline stress, be able to cope with multiple tasks, and be able to prioritize tasks without supervisor input;
- Excellent English written and oral communication skills;
- Fluency in more than one European language from a country in which Illumina has a significant presence, preferably France or Germany, to a level that will allow effective negotiation and discussion with regulators and policy makers
- Ability to gather, write, edit and facilitate assembly of memos, and process product and system information for regulatory purposes
- Strong work ethic and demonstrated ability to deliver assignments on time.
- Bachelor’s degree or equivalent in science or related field required;
- Regulatory Affairs Certification preferred;
- Additional coursework in regulatory or quality assurance strongly desired.
This is your chance to join an initiative in its early stages of development and to have real impact and visibility. This role has great growth opportunities in a newly formed team that is key to Illumina’s growth and success for the future. Interested parties will need to apply via the Illumina careers website:
All About Us
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.
lllumina has experienced phenomenal growth from $10 million in revenues in 2002 to approximately $2.2 billion in 2015. Forbes named Illumina #1 on the 2009 list of 25 Fastest-Growing Technology Companies in the United States, the second time over a three year period that Forbes ranked Illumina #1 on its list of rapidly growing technology companies. Illumina was also named #1 smartest company in the world as part of MIT’s 2014 Technology Review. As of February 2016, the company had a $21 billion market capitalization.
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.