Find Senior medical social Jobs in Dublin, D

Senior Specialist Device Technical Regulatory
Viatris —Northern Cross, County Dublin
- Full-time
- Engineering
- English
- Master's degree
Reconciliation Technology Specialist, Delivery Manager, VP
Sumitomo Mitsui Banking Corporation —Dublin, County Dublin
- €72,000–€134,000 a year
- Hybrid work
- Contracts
- Communication skills
- Annual leave
Change Manager (IAM)
Expleo —Dublin, County Dublin
- Microsoft Powerpoint
- Microsoft Excel
- Project management
14d
Nursing Site Manager
Blackrock Health Hermitage Clinic —Lucan, County Dublin
- Full-time
- Management
- Clinic
- IT
- Annual leave
- Employee assistance program
Quick apply
PERM - OPPD - Enterprise Business Management - Vice President
Sumitomo Mitsui Banking Corporation —DUBLIN 2, County Dublin
- €65,000–€121,000 a year
- Hybrid work
- Analysis skills
- Communication skills
- Banking
- Annual leave
Physical Trainer | Dublin - Full Time
Siel Bleu Ireland —Dublin, County Dublin
- €25,000–€28,000 a year
- Full-time
- English
- Master's degree
- Communication skills
- Wellness program
- Work from home
Quick apply
8d
Data Platform Squad Lead
Sumitomo Mitsui Banking Corporation —Dublin, County Dublin
- €72,000–€134,000 a year
- Hybrid work
- Computer Science
- Master's degree
- Bachelor's degree
- Annual leave
Human Resources Business Partner
Blackrock Health Hermitage Clinic —Lucan, County Dublin
- Full-time
- Microsoft Excel
- Clinic
- Analysis skills
- Employee assistance program
Quick apply
Graduate Sales Operations Analyst
Analog Devices —Dublin, County Dublin
- Full-time
- Microsoft Excel
- Sales
- Time management
2d
Associate - Health Services
Byrne Wallace Shields —DUBLIN 2, County Dublin
- Full-time
- Hybrid work
- Research
Quick apply
10d
Director, Employee Benefits Consulting
WTW —Dublin, County Dublin
- Full-time
- Hybrid work
- Mentoring
- Communication skills
- Annual leave
Senior QA Automation Engineer, Charles River Development
State Street —DUBLIN 2, County Dublin
- Full-time
- Azure
- Oracle
- Computer Science
Senior Data Engineer
Expleo —Dublin, County Dublin
- SQL
- AWS
- Analysis skills
8d
Project Engineer R&D
Embecta —Dún Laoghaire, County Dublin
- Full-time
- Engineering
- Bachelor's degree
- Communication skills
Total Rewards Manager
The Maples Group (Financial Services) —DUBLIN 2, County Dublin
- Full-time
- Research
- Analysis skills
- Organisational skills
- Life insurance
Senior Manager, Core Labelling Strategy (12 month agency contract)
Viatris —Northern Cross, County Dublin
- Full-time
- Management
- Doctoral degree
- Master's degree
Occupational Therapist
Healthcare Direct —Dublin, County Dublin
- Weekend availability
- Mentoring
- Annual leave
Quick apply
Senior Physiotherapist in Cystic Fibrosis
Beaumont Hospital —Dublin, County Dublin
- Full-time
- Master's degree
- No degree
1d
Sr. Client Account Manager, French Market
Pinterest —Dublin, County Dublin
- €73,664–€128,912 a year
- Sales
- English
- Master's degree
- Relocation assistance
14h
Director Global Regulatory Compliance (Process Excellence)
Viatris —Northern Cross, County Dublin
- Full-time

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Senior Specialist Device Technical Regulatory

Viatris -
Northern Cross, County Dublin

Apply Now

Job details

Full-time

Qualifications

Engineering
English
Master's degree
Bachelor's degree

Full 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

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

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.

Apply Now

Refine Your Search

senior medical social jobs in dublin, d

Senior Specialist Device Technical Regulatory

Reconciliation Technology Specialist, Delivery Manager, VP

Change Manager (IAM)

Nursing Site Manager

PERM - OPPD - Enterprise Business Management - Vice President

Physical Trainer | Dublin - Full Time

Data Platform Squad Lead

Human Resources Business Partner

Graduate Sales Operations Analyst

Associate - Health Services

Director, Employee Benefits Consulting

Senior QA Automation Engineer, Charles River Development

Senior Data Engineer

Project Engineer R&D

Total Rewards Manager

Senior Manager, Core Labelling Strategy (12 month agency contract)

Occupational Therapist

Senior Physiotherapist in Cystic Fibrosis

Sr. Client Account Manager, French Market

Director Global Regulatory Compliance (Process Excellence)

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