Regulatory Affairs Lead Europe
- Flexible / Remote
Location: Remote from Europe
Invitae is dedicated to bringing genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry, by making clinical-grade genetic information affordable and accessible to guide health decisions across all stages in life.
Our team is expanding and we are looking for people who are passionate about helping improve healthcare to join us.
We are seeking an experienced Regulatory Affairs professional who has experience in international registrations and submissions working in the pharmaceutical, diagnostic and/or medical device industries. The successful candidate will have extensive knowledge and experience in various regional regulations including FDA, EU, APAC, LATAM, etc. The successful candidate must be a strategic thinker, able to evaluate and act on various complex scenarios involving co-development programs of drug and diagnostics, with ability to manage aggressive timelines. Strong regulatory affairs expertise in IVD's is preferred for the successful candidate, who also must ensure all Regulatory Affairs and Quality Design Assurance systems are established, implemented, and maintained in accordance with applicable standards for the company.
What you will do:
- Works closely with Regulatory Affairs, Quality, Medical Affairs and Commercial in establishing and implementing strategies and timelines
- Develops and implements strategies for timely submission and approval of regulatory submissions for products for specific countries and regions
- Ensures the accurate and timely preparation of regulatory submissions and reporting in accordance with goals, regulatory requirements and partnership contracts
- Interfaces with various country’s regulatory agencies and other regulatory agencies in connection with submission, approvals, and audits
- Responsible for designated Site Registrations, Product Registrations, Shipping Kit Registrations and Software Registrations
- Will participate in BioPharm partnership regulatory affairs assessments, as well as product support and post market support.
- Participates in committees and Project Teams as an international representative of Regulatory Affairs
- Prepares and presents project status reports, strategy and initiatives
- Works across teams formulating regulatory processes/procedures and shares best practices/knowledge with regulatory colleagues
- Stays abreast of global regulations and guidance's, especially those relevant to genomic diagnostics
Who you are:
Education and Qualifications:
- Minimum of 5 years of Regulatory Affairs experience with specific region and country regulatory expertise which includes IVD registrations
- Bachelor’s degree in science or applicable field of study, higher degrees are preferred
- Regulatory Affairs Certificate (RAC, Medical Device Certificate)
- Working knowledge of applicable Clinical, Data Management and External Site Services function regulations and guidances (GCP/GLP/cGMP/GDP E-records & E-signatures) regulations and related guidelines
- Working knowledge of ISO 15189 and ISO 13485 accreditation
- Excellent oral and written communication skills
- Ability to organize and manage multiple priorities
- Excellent time management skills
- Attention to detail, tactful, and diplomatic
- Proficiency with Microsoft Office and general computer knowledge
- Ability to travel, as needed
By joining Invitae, you’ll work alongside some of the world’s experts in genetics and healthcare at the forefront of genetic medicine. We’ve created a culture that empowers our teams and our teammates to have the biggest impact and to explore their interests and capabilities. We prize freedom with accountability and offer significant flexibility, along with excellent benefits and competitive compensation in a fast-growing organization.
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
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