Austin Vita has a fantastic opportunity for a Senior Regulatory Affairs Specialist with IVD experience, to join a newly formed clinical business unit in a global company where you will be part of the Regulatory Team for IVD's including; Class A and Class B - Instrumentation, Re-agent Kits, Consumables, Accessories, Hardware etc so would suit someone who would love to work across a broad IVD product spectrum.
You will provide regulatory input to new product development teams to ensure product requirements/design inputs and design outputs enable identified planned regulatory filings, and will prepare, execute and maintain regulatory filings including change management, support of post market requirements and support of outside vendors (e.g. license holders, in country representatives)
- Act as SME and Regulatory Affairs lead for the new product development projects, providing solution-based advice to development teams.
- Develop and maintain regulatory strategies for new and modified product / product families.
- Prepare and execute regulatory filings such as pre-IDEs, premarket notifications, technical files, Canadian submissions, and letters to file.
- Provide regulatory guidance on changes to existing products.
- Monitor global regulatory intelligence, provide impact evaluation to changing regulations.
- Provide regulatory input to support post market surveillance and vigilance activities.
- Act as Subject Matter Expert within 3rd party and internal audits.
- Bachelor's degree required preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education is preferable
- Solid regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent
- Knowledge and application of 21 CFR 820 and ISO 13485 is required
- Knowledge and application of the European IVD regulations is required, IVDR preferred
- First-hand experience with preparation and execution of regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval, preferably for clinical IVD products
- Able to work effectively in a global function
- Ability to manage and influence in a complex, global matrix organization
- Strong ability to work with individuals/teams dispersed across many different locations and cultures
- Strong organisation/prioritisation skills.
You will be rewarded with a great salary and benefits package, flexible working, and relocation package is also on offer.
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.