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Delivering/exceeding AOP for orders, sales and managing distributors and direct sales in Central Eastern Europe Middle East & Africa

Here at Waters, we are looking for a Principal Regulatory Affairs Specialist to join our brand new Clinical Business Unit! We are looking for someone to take ownership for the determination and execution of In Vitro Diagnostic regulatory strategy including provision of regulatory input to our new product development teams to ensure product requirements/design inputs, study design of pre-clinical/clinical trials and design outputs including assessment of clinical evidence enable identified planned regulatory filings. You'll craft and implement regulatory strategy to expand scope of use and geographic registration of our current Waters IVD portfolio. Alongside this, you'll prepare, implement and maintain regulatory filings including change management, support of post market requirements and support of outside vendors [e.g. license holders, in country representatives]. This role reports to the Senior Director, Regulatory and Clinical Affairs will partner with multiple levels and functions within the Clinical Business Unit organization to support the growth of the IVD product portfolio. This role will be hybrid with around 25% of the time spent in the office with the rest remote. There will also be around 25% travel.  What can we offer you?- A plan for your personal development in your own area of specialism, pursuing this with the support of your manager to undertake the training and learning to progress- Competitive salary- 25 days annual leave- Private health and dental insurance- Contributory based pension scheme- Subsidized membership of onsite gym- EAP (Employee Assistance Program)The above benefits apply to Wilmslow employees. Specific benefits relating to Wexford or other European sites will be discussed during the interview stage.