Regulatory Affairs Specialist
1 day ago
Are you passionate about navigating global regulatory landscapes for innovative
medical devices? Do you thrive in a fast-paced, entrepreneurial environment?
We are seeking a Regulatory Affairs Associate to drive compliance and regulatory submissions worldwide for state-of-the-art medical technologies. This is an exciting opportunity to collaborate with cross-functional teams and ensure adherence to the latest global standards and regulations.
What you’ll do:
- Manage regulatory submissions, including CE mark, FDA, and global filings.
- Maintain compliance with ISO 13485, ISO 14971, EU MDR, US 21 CFR 820, and MDSAP.
- Provide strategic regulatory insights during product development.
- Support audits, post-market surveillance, and risk management activities.
What we’re looking for:
- Bachelor’s degree in Engineering or Science with 4+ years in medical device regulatory affairs.
- Proven experience in EU MDR and US FDA regulations (certifications desirable).
- Exceptional project management and organizational skills.
- Self-motivated team player with excellent communication skills.
Join a team dedicated to improving patient outcomes and shaping the future of medical technology. If you’re detail-oriented, proactive, and eager to make an impact, we want to hear from you
Apply now to take the next step in your regulatory career.
#J-18808-Ljbffr
-
QA Specialist
2 weeks ago
Clonmel, Ireland Quanta Consultancy Services Ltd Full timeQA Specialist - Life Science - Contract - Clonmel Our Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Clonmel for over 40 years, exports to over 25 countries around the world with primary...
-
Accounts Payable Specialist
2 weeks ago
Clonmel, Ireland Cpl Healthcare Full timeMy client is looking for an Accounts Payable Specialist to join their team on a permanent basis. Reporting directly to the Senior Financial Accountant, you will be a key member of the Finance Administration Team responsible for processing supplier invoices, making daily cash payments, bank postings, monthly Revenue regulatory returns, and any month-end and...
-
EHS Specialist
2 weeks ago
Clonmel, Ireland PSC Biotech Corporation Full timeTipperary, Ireland | Posted on 12/20/2024 - Industry: Pharma/Biotech/Clinical Research - Work Experience: 5+ years - Country: Ireland Job Description About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and...
-
Staff IT Operations Reporting Specialist
2 days ago
Clonmel, Ireland Regeneron Pharmaceuticals, Inc Full timeThe Staff IT Operations Reporting Specialist ensures the delivery of high-quality services to end users, focusing on developing, managing, and optimizing reporting processes to support operational excellence in a highly regulated GxP environment. This role requires a deep understanding of data analytics, reporting tools, and the ability to translate complex...
-
Quality Design Engineer
2 weeks ago
Clonmel, Ireland Boston Scientific Gruppe Full timeDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and...
-
Clonmel, Ireland PSC Biotech Corporation Full timeTipperary, Ireland | Posted on 12/20/2024 - Industry: Pharma/Biotech/Clinical Research - Work Experience: 5+ years - Country: Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US,...
-
Compliance Manager
2 weeks ago
Clonmel, Ireland Abbott Laboratories Full timeHave you ever wanted to make a difference? At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and...
-
Compliance Manager
2 weeks ago
Clonmel, Ireland Abbott Laboratories Full timeHave you ever wanted to make a difference? At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and...
-
Apply Now! Compliance Manager
2 weeks ago
Clonmel, Ireland Abbott Laboratories Full timeHave you ever wanted to make a difference? At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and...
-
Senior Principle Engineer – Process Automation
2 weeks ago
Clonmel, Ireland Eli Lilly and Company Full timeSenior Principle Engineer – Process Automation At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management...