Senior Regulatory Affairs Specialist

Boston Scientific; Clonmel; On-site; EUR 90,000 - 120,000; Full time

Job summary

Boston Scientific in Ireland seeks a Senior Regulatory Affairs Specialist on a permanent basis to join our team. This role can be based at Galway, Clonmel, Cork in Ireland or Maple Grove, US.

You will plan, manage, and implement regulatory submissions to FDA and EU authorities, maintain approvals, and perform change impact reviews. You’ll collaborate across product development, manufacturing, QA and compliance to sustain registrations and support audits.

Qualifications

• 4+ years in Regulatory Affairs or related discipline for medical devices.
• Experience authoring or supporting US FDA submissions and EU MDR documentation.
• Knowledge of design controls and product development processes.
• Strong written and oral communication and technical writing skills.

Responsibilities

• Support development of domestic and international strategies for Class II and III medical devices
• Represent RA on cross-functional projects including product development and manufacturing changes
• Review and approve design and manufacturing changes for existing products
• Coordinate and submit US and EU regulatory filings (PMAs, 510(k), CE Mark under MDR)
• Support international geographies to gain and maintain product approvals
• Assist in regulatory audits and continual improvement efforts

Skills

Regulatory Affairs

Medical devices

Technical writing

Project management

Cross-functional collaboration

Education

Bachelor's degree (Level 8) in Engineering or related field

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Job description

Diversity - 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 training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

We are seeking a Senior Regulatory Affairs Specialist on a permanent basis to join our team. This role can be based out of any of the following sites: Ireland-Galway; Ireland-Clonmel; Ireland-Cork; US-MN-Maple Grove

About The Role

Join our Vascular Therapies Team, where we create innovative technologies to diagnose and treat peripheral vascular disease. Our products improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions.

The Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

Your Responsibilities Will Include

• Support the development of domestic and international strategies for Class II and III medical devices
• Represent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR
• Support international geographies to gain and maintain product approvals
• Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
• Supporting regulatory audits, as required

Required Qualifications

• Level 8 Hons Bachelor Degree (or higher) in Engineering or related field
• 4+ years Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling, etc)
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as US 510(k)s and EU MDR technical documentation
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
• Previous experience supporting medical electrical equipment
• General understanding of product development process and design controls
• Working knowledge of US FDA, EU, and international regulations
• Ability to manage several projects
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments
• Team player with excellent interpersonal skills

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email [e-mail].