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, flexible working and relocation package also on offer, 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.