Senior Specialist Device Technical Regulatory

The Role & What You Will Be Doing Every day

• Experienced in the application of FDA and EU regulations and guidances related to design control, regulatory compliance and applicable ISO standards.
• Has an understanding of, and maintained awareness of, current regulations and regulatory guidance in regions of interest to Viatris development programs, including, but not limited to, the EU and the US.
• Actively collaborate within both the Device Technical Regulatory function and wider Global Device Development (GDD) on the development of regulatory strategies for combination products and medical devices.
• Lead the Device Program Teams (DPTs) in the implementation and execution of strategies and plans that ensure compliance to regulations, legislations, regulatory guidelines and standards.
• Lead the DPTs in their awareness of current regulatory best practice when building device development plans.
• Collaborate within DPTs to generate regulatory plans (for example, for meeting requests and submissions) which are aligned with the overall program level timelines.
• Collaborate within DPTs to ensure regulatory strategies are disseminated and understood and aligned with the key milestones and critical path activities of the program.
• Author and review (and drive the authoring and review) of documents for regulatory submissions; including, but not limited to, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Application (BLA), Marketing Authorisation Applications (MAAs), Notified Body Opinion (NBOp) applications, variations and other related activities (e.g., meeting requests and planning and execution).
• Ensure timely feedback to GDD Management Team (MT) and DPT on the outcomes of meeting/agency feedback with consideration to program and portfolio level consequences.
• Actively support the learning and development of the Device Technical Regulatory team.

About Your Skills & Experience

• Bachelor's degree in a scientific/engineering discipline.
• A Masters or higher degree desirable.
• Broad experience in the Medical Device and/or Drug-Device Combination Product industry.
• Knowledge and demonstrable experience of global Medical Device and Drug-Device Combination Product regulatory requirements and regulatory planning including but not limited to 21CFR820 and MDR (EU)2017/745.
• Knowledge and demonstrable experience of global Medical Device and Drug-Device Combination Product quality requirements including but not limited to device design controls in accordance with ISO13485 and 21CFR820.10(c).
• Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment, with a significant proportion having a drug delivery/device focus.
• Experience, at a team level, in device development programs, specifically with a focus on the preparation and delivery of device technical regulatory submission content.
• Demonstrable track record of competence in leading device program teams in problem solving approaches to device technical regulatory issues.
• Excellent communicator; clear and concise in communications, both written and verbal.
• Strong team player that is willing to take on and support other activities outside core expertise as required to develop the future of the department.
• Proficiency in speaking, comprehending, reading and writing English is required.
• At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits at Viatris

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Viatris is an Equal Opportunity Employer.