Austin Vita has a fantastic opportunity for a Principal Regulatory Affairs Specialist with IVD experience, particularly for EU and US, to join a newly formed clinical business unit in a global company where you will be the Regulatory SME for IVD's and have responsibility for providing regulatory strategy, regulatory guidance to new product development team, mentoring Regulatory Specialists and project management of assigned regulatory programs.
This will include; post market surveillance requirements, knowledge of study design of pre-clinical/clinical trials, identify and assess clinical evidence required to support In Vitro Diagnostic medical devices, reviewing promotional materials, supporting health hazard assessments, and reviewing design change assessments.
Working with new product development teams providing regulatory guidance, regulatory and clinical strategy
Act as the point of contact with Worldwide Competent Authorities, Notified Bodies
Support Quality Organisation with any external inspections and audits
Lead Worldwide registration team, provide local agents' evaluation, and support contractual agreements
Lead the IVDR transition activities
Provide regulatory guidance for changes to existing products
Monitor global regulatory intelligence, provide impact evaluation to changing regulation and provide mitigation approach
Develop and maintain regulatory and clinical strategies for new and modified products
Preparing regulatory filings such as pre-IDEs, premarket notifications, technical files, Canadian submissions, and letters to file
Manage and maintain Regulatory Affairs internal policies and procedures
Perform regulatory research to find predicate and support new product development as needed
Performing regulatory impact assessments for engineering changes for hardware and software
Review and approve promotional materials, product labels and labelling as well as advice on language requirements worldwide
Support Health Hazard Assessments and Field Actions as needed
Provide guidance to regulatory specialists as needed to support clinical strategy requirements
Mentor regulatory specialists on clinical evidence
Oversee outside vendors such as agents and CROs as needed
Oversee, maintain, and develop departmental policies, procedures and forms required to ensure compliance with applicable laws and regulations
Bachelor's degree preferably in Analytical Chemistry, Biochemistry, or Biomedical Graduate education is preferable
Minimum of 6 years regulatory affairs experience in the In Vitro Diagnostic Medical Device environment supporting worldwide regulatory and clinical strategy for new and changed IVD medical devices
Knowledge of 21 CFR 820 and ISO 13485 is required
Knowledge of the US and European IVDR regulations is required
Knowledge of LC/MS and (SaMD) software as a medical device regulation
First-hand experience with FDA interactions (510(k), IDE, PMA, pre-submissions)
First-hand experience transitioning products from compliance with EU directives to regulations
Experience reviewing clinical/performance evaluation reports and literature searches/reviews
Experience managing vendor selection and performance
Strong organisation/prioritisation skills
Team player demonstrating good organisational and communication skills
Self-starting demonstrating initiative
You will be rewarded with a great salary and benefits package, and flexible working, and enjoy seeing the success and growth of this newly formed business unit.
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.