Find Regulatory affairs global Jobs in Balbriggan, D

Certification & Compliance Specialist
Sanbra Fyffe Ltd- Instantor —Santry, County Dublin
- €68,000–€80,000 a year
- Full-time
- Engineering
- Analysis skills
- Project management
Quick apply
5d
Head of Global Regulatory Strategy, Global Regulatory Affairs
Viatris —Northern Cross, County Dublin
- Full-time
- Doctoral degree
- Master's degree
- Business
Director Regulatory Affairs Global CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Project management
- Mentoring
- Manufacturing
Senior Regulatory Affairs Officer (12 Month FTC)
Viatris —Northern Cross, County Dublin
- Full-time
- Bachelor's degree
- Time management
Senior Manager, Global Regulatory Affairs – Business Process
Viatris —Northern Cross, County Dublin
- Full-time
- Project management
- No degree
Manager Corporate Drug Regulatory Affairs (12 month agency contract)
Viatris —Northern Cross, County Dublin
- Full-time
- English
- Bachelor's degree
- Communication skills
Senior Specialist Regulatory Operations (Electronic Submissions)
Viatris —Northern Cross, County Dublin
- Full-time
- Marketing
- English
- Microsoft Office
- Employee assistance program
Senior Specialist Regulatory Key Initiatives
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Word
- Microsoft Excel
- Bachelor's degree
Senior Manager, European Regulatory Policy and Intelligence
Viatris —Northern Cross, County Dublin
- Full-time
- Communication skills
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Senior Manager, Global Device Quality
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Word
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Senior Manager, Regulatory Affairs CMC
Viatris —Northern Cross, County Dublin
- Full-time
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Director Global Regulatory Compliance (Process Excellence)
Viatris —Northern Cross, County Dublin
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Assistant Manager, GRA Business Process
Viatris —Northern Cross, County Dublin
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- SharePoint
8d
Director Regulatory CMC Sciences Project Management
Viatris —Northern Cross, County Dublin
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Specialist RIM Data Maintenance
Viatris —Northern Cross, County Dublin
- Full-time
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- Bachelor's degree
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Director Respiratory Regulatory CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
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Certification & Compliance Specialist
Sanbra Fyffe Ltd- Instantor —Santry, County Dublin
Proven in-depth knowledge and practical experience with key international regulatory frameworks and standards relevant to regulated products (e.g., Construction…
€68,000–€80,000 a year
Quick apply
5d

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Certification & Compliance Specialist

Sanbra Fyffe Ltd- Instantor
Santry, County Dublin

Quick apply

Job details

Permanent | Full-time
€68,000–€80,000 a year
5 days ago

Qualifications

Law
Engineering
Quality management
Analysis skills
Project management
Bachelor's degree
Communication skills

Full job description

About Us

Home to the iconic Instantor® Brand, Sanbra Fyffe is a market leader in the manufacturing, wholesale and distribution of plumbing supplies to the builder’s merchants trade for 90 years.

At Instantor, our values aren’t just words on a page - they shape how we work, support each other, and deliver for our customers. We’re looking for someone who shares these values and wants to thrive in a collaborative, customer-focused environment.

Our Values

Teamwork: All departments within the business act as one team to make Sanbra Fyffe the best it can be.

Customer Focus: We commit to meet and exceed our customer’s expectations, by placing the customer at the centre of all our decisions.

Quality & Reliability: We focus on doing things the right way, the first time; delivering on quality, on time and on cost.

Expertise: We develop and manufacture solutions to provide our customers with maximum value.

Role Purpose

We are seeking a highly experienced and proactive Certification & Compliance Specialist to lead our efforts in navigating the complex landscape of international regulations and standards. We are an award winning, well-established Dublin based manufacturing/wholesale business synonymous with offering market leading brands conforming and certified to the most stringent quality standards.

The sustainable development of new quality products and enhancement of existing products has been key to the success of this business. The Certification & Compliance Specialist will be responsible for defining, implementing, and maintaining our global regulatory compliance strategy across all product lines. This pivotal role will ensure that all products comply with relevant national and international safety, performance, and environmental standards, facilitate successful product approvals, and manage all interactions with Notified Bodies and other regulatory authorities. The Certification & Compliance Specialist will work alongside our ESG, Quality, Technical and NPD teams to assist us to continue develop our product offering so that we can keep ahead of market trends and meet customer needs while achieving our compliance and sustainability goals and objectives.

Key Responsibilities

Regulatory Strategy & Oversight

Develop, implement, and maintain a comprehensive regulatory compliance strategy for all products, ensuring alignment with business objectives and changing regulatory standards.
Monitor new and evolving national and international regulations, standards, and directives relevant to our product ranges (e.g. CE, LVD, EMC, RoHS, DWD, PPWR, ESPR, etc.).
Provide guidance and support to R&D, Quality, Manufacturing, Sales, and Marketing teams on regulatory requirements throughout the product lifecycle, from concept to end-of-life.
Proactively identify potential regulatory opportunities and risks, developing mitigation strategies and action plans.

Product Approvals & Certification

Manage and oversee all aspects of product approvals and certifications for new and existing products across various markets.
Prepare and submit comprehensive technical documentation, test reports, and declarations of conformity to Notified Bodies, certification agencies, and regulatory authorities.
Coordinate and facilitate all necessary product testing with internal and external laboratories to ensure compliance with relevant standards.
Maintain and update all product certifications and declarations, ensuring their ongoing validity.

Notified Body & Regulatory Authority Interactions

Act as the primary point of contact and lead all interactions with Notified Bodies, national regulatory authorities, trade bodies and other certification bodies.
Respond to inquiries, address deficiencies, and negotiate with regulatory bodies to achieve timely product approvals and resolve compliance issues.
Build and maintain strong working relationships with key regulatory stakeholders.

Documentation & Quality Management Systems

Establish and maintain robust regulatory documentation systems, ensuring accurate, complete, and readily accessible records of all approvals, certifications, and compliance activities.
Collaborate with the Quality team to integrate regulatory requirements into the company's Quality Management System (e.g., ISO 9001).
Develop and deliver training programs to internal teams on upcoming regulatory changes and regulatory compliance requirements and best practices.
Ensure all product labelling, user manuals, and marketing materials comply with relevant regulatory requirements.

Post-Market Surveillance & Compliance Maintenance

Support post-market surveillance activities, including the review of product complaints and incidents for potential regulatory impact.
Manage and track changes to existing products to ensure continued compliance with evolving regulations.
Work closely with relevant trade bodies to gather information on upcoming regulatory changes to ensure ongoing compliance.

Requirements

Essential

Bachelor's degree in Engineering, Science, Law, or a related technical discipline.
Minimum of 3 years of experience in a dedicated Product Regulatory role within a manufacturing environment.
Proven in-depth knowledge and practical experience with key international regulatory frameworks and standards relevant to regulated products (e.g., Construction Products Regulation (CPR), Low Voltage Directive (LVD), EMC Directive, WRAS (DWD), EPDs, etc).
Demonstrable experience in managing complex product approval processes from start to finish, including interactions with Notified Bodies.
Strong understanding of quality management systems (e.g., ISO 9001) and their application in a regulatory context.
Excellent written and verbal communication skills, with the ability to articulate complex regulatory information clearly and concisely to diverse audiences.
Highly organised, meticulous, and detail-oriented, with strong project management skills.
Proactive, self-motivated, and able to work independently as well as collaboratively within a team.

Desirable

Experience in certifications and approvals within the construction industry.
Previous experience in creating and managing EPDs.
Legal background or specific qualification in regulatory affairs.

Skills & Competencies

Highly organised with excellent attention to detail.
High level of integrity and ethical conduct.
Strong analytical and problem-solving abilities.
Resilience and adaptability in a fast-paced, evolving regulatory landscape.
Commitment to continuous learning and professional development.

Pay: €68,000.00-€80,000.00 per year

Work Location: In person

Quick apply

Refine Your Search

regulatory affairs global jobs in balbriggan, d

Certification & Compliance Specialist

Head of Global Regulatory Strategy, Global Regulatory Affairs

Director Regulatory Affairs Global CMC

Senior Regulatory Affairs Officer (12 Month FTC)

Senior Manager, Global Regulatory Affairs – Business Process

Manager Corporate Drug Regulatory Affairs (12 month agency contract)

Senior Specialist Regulatory Operations (Electronic Submissions)

Senior Specialist Regulatory Key Initiatives

Senior Manager, European Regulatory Policy and Intelligence

Senior Manager, Global Device Quality

Senior Manager, Regulatory Affairs CMC

Director Global Regulatory Compliance (Process Excellence)

Assistant Manager, GRA Business Process

Director Regulatory CMC Sciences Project Management

Specialist RIM Data Maintenance

Director Respiratory Regulatory CMC

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