Senior Specialist Device Technical Regulatory

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Diversity & Inclusion at Viatris

Job summary

McDermott Laboratories Limited Viatris is seeking a Senior Specialist, Device Technical Regulatory to apply FDA and EU regulations, lead regulatory strategies for combination products and medical devices, and collaborate across the Global Device Development function.

The role requires leadership across device programs, knowledge of global regulatory standards, and the ability to author regulatory submissions and guidance documents for complex products.

Qualifications

• 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 including 21 CFR 820 and MDR (EU) 2017/745.
• Knowledge of global Medical Device and Drug-Device Combination Product quality requirements including ISO 13485 and 21 CFR 820.10(c).
• Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment, with a significant focus on drug delivery/device.

Responsibilities

• Lead Device Program Teams in implementing regulatory strategies and plans.
• Collaborate within Device Technical Regulatory and Global Device Development to align regulatory plans with program timelines.
• Author and review regulatory submissions (NDA, ANDA, BLA, MAAs, NBOp) and related activities.
• Ensure timely feedback to GDD Management and DPT on agency interactions and outcomes.
• Support learning and development of the Device Technical Regulatory team.

Skills

Regulatory strategy

FDA & EU regulations

Design controls ISO 13485

Cross-functional leadership

Regulatory submissions

Education

Bachelor’s degree in a scientific/engineering discipline

Masters or higher degree desirable

Job description

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 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

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension
• Diversity & Inclusion at Viatris

Diversity & Inclusion

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

Viatris is an Equal Opportunity Employer. Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.