Senior Risk Management Engineer / Scientist

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

Job summary

Viatris is expanding its Global Device Development team and seeks a Senior Risk Management Engineer/Scientist to lead RM processes for combination products and devices. You will collaborate with Quality, Clinical and Pharmacovigilance to ensure RMFs stay current, compliant and effective across the product lifecycle.

The role requires experience in ISO 14971:2019, FDA 21 CFR 820, and global RM practices, with a focus on cross-functional leadership and timely risk communications.

Qualifications

• Degree with proven direct experience in regulated Pharma/Medical Device/GMP environment.
• Ability to work independently and with cross-functional teams.
• Excellent communication to lead stakeholders and teams.

Responsibilities

• Lead RM process implementation for combination products/devices.
• Provide SME support across device lifecycle including regulatory submissions.
• Drive process improvements for high-quality program delivery.
• Develop RM principles, processes and procedures for up-to-date RM practices.
• Lead Device Program Teams in RMF deliverables (FMEA, FTA, hazard lists).
• Contribute to regulatory submissions, responses and audits.
• Assess RMFs against on-market data and update post-market activities.

Skills

Excellent communication

Independent worker

Problem solving

Education

Degree in regulated Pharma/Medical Device

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. Our Global Device Development organization is an innovative, technically strong, and fully integrated team focused on delivering high-quality, safe, and effective device and combination products to meet evolving patient healthcare needs worldwide. It provides leadership, strategic oversight, direction, support, and hands-on training for medical devices and combination products. Through thorough knowledge, this role will support the establishment, maintenance and remediation of risk management files for combination products and devices under development, on-market or acquired. A key focus of this role shall include critical engagement with on-market stakeholders including Quality, Clinical, and Pharmacovigilance to support the monitoring of product performance and safety Every day, we rise to the challenge to make a difference and here’s how the Senior Risk Management Engineer/ Scientist role will make an impact:

Key responsibilities for this role include:

• Be responsible for combination product / device Risk Management (RM) process implementation and thought leadership, to ensure the strategic development of Risk Management Files (RMFs), to meet the intended global business needs, in compliance with relevant regulations, standards, guidance and procedures.
• Lead within the GDD Risk Management function, taking responsibility for developing and delivering subject matter expertise to cross-functional teams across the full device lifecycle, including global regulatory submissions, product launch, and post-market support.
• Seek to identify and lead the implementation of process improvements across GDD’s processes, to ensure high quality, efficient program delivery.
• Within RM group, lead and contribute to, the development of RM principles, and associated processes and procedures, to ensure that GDD operates with the latest RM practices to ensure State of the Art (SOTA).
• Under assigned design and development programs, lead Device Program Teams (DPTs) in the development of Risk Management File deliverables including, but not limited to, Failure Mode Effects Analysis (FMEA), Fault Tree Analysis, Medical Hazard Lists, and clinical trial preparation, against the defined design control / design and development timelines.
• Contribute to regulatory submissions, regulatory responses, and external/ third party audits as required by the organization.
• Assess Risk Management Files (RMFs) against on-market data and apply risk-based thinking to post-market sustaining activities to maintain the RMF’s contemporaneousness.
• Collaborate with Device Development colleagues, Product Quality Oversight, Clinicians and Pharmacovigilance teams, through application of RM throughout the product Life-Cycle process to analyse, evaluate, mitigate and control risks, in line with International Standards, Regulatory requirements and local Quality Management System (QMS).
• Lead and support the assessment of Change Controls (CC), Complaint Investigations, CAPAs and Quality Incidents, as applicable.
• Communicate clearly and in a timely manner to program teams and within the functional line team to ensure potential and theoretical risks are identified and communicated in a constructive and timely manner.
• Maintain detailed awareness and understanding of global risk management requirements for medical devices and drug-device combination products in regions of interest to the Viatris portfolio.
• Collaborate as part of “One Team”, with a common purpose of delivering high quality device / combination products, that are safe and effective for users.

The minimum qualifications for this role are:

• Degree with proven direct experience, in a regulated Pharma/Medical Device/ GMP environment.
• A team player willing to support any other organisational needs/activities outside primary expertise to continuously develop the business.
• Ability to work independently and with minimal direction.
• Ability to define, organize, and manage individual and team tasks.
• Excellent communication and collaborative skills to lead or facilitate effective discussions.
• Able to communicate technical information to key stakeholders.
• Experienced in design and development (ISO 13495 / 21CFR 820.) and Risk Management (ISO 14971:2019).
• Familiarity with new product introduction/ development (NPI)/ NPD) and/ or Lifecycle Management / Sustaining.
• Demonstrable ability to execute to program deliverables and timelines.
• Strong problem solving and analytical skills.
• Detail-orientated without compromising on project timelines.
• Demonstrable understanding and application of the fundamental principles of Medical Device Risk Management within the regulatory framework of FDA 21 CFR 820.30 and EUMDR 2017/745.
• Demonstrable understanding and application of Design, Use and Manufacture risk-related analysis methodologies, including but not limited to FMEAs, FTAs and Medical Hazard Analysis.

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.

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.

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.