Senior Specialist Device Technical Regulatory

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McDermott Laboratories Limited Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing Every day, we rise to the challenge to make a difference and here's how the Senior Specialist, Device Technical Regulatory role will make an impact: 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 For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences: 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 21 CFR 820 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 ISO 13485 and 21 CFR 820.10(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 ex

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