Regulatory Affairs Manager I

Cork - Ireland

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

Advancing possibilities for a brighter tomorrow

We are seeking a Regulatory Affairs Manager I on a permanent basis to join our team. This role can be based out of our Cork or Galway sites in Ireland.

Job Purpose:

The Interventional Oncology and Embolization (IO&E) division at Boston Scientific offers the broadest portfolio of solutions enabling physicians to treat tumors using targeted and localized embolic and ablative technologies. We are committed to transforming lives through minimally invasive innovationsand to expanding our impact across high-growth global markets.

The Regulatory Affairs (RA) Manager will lead a team of five Regulatory Affairs Specialists providing training strategic guidance and professional development support. This role plays a critical part in maintaining regulatory compliance and driving operational excellence across the IO&E portfolio.

Key Responsibilities:

Demonstrate people leadership commitment through coaching meaningful conversations career development driving continuous improvement enhancing leadership capability and leading inclusively.
Establish and lead a Regulatory Affairs Operational Excellence team which will support EU MDR maintenance activities for the IO&E product portfolio.
Provide training and guidance to employees on EU MDR maintenance activities to ensure continued compliance and audit readiness
Provide training to new and junior employees on performing and documenting regulatory affairs assessments for supplier manufacturing and design changes.
Provide guidance to employees on the development of global regulatory affairs strategies for new product development projects.
Perform regulatory affairs management review of submissions to regulatory agencies
Attending monthly Notified Body meetings on behalf of the IO&E division.
Oversee audit preparation activities and serve as the primary point of contact during audits.
Conduct weekly oneonone meetings with direct reports and lead structured quarterly development conversations.
In all actions demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Education & Experience:

A Level 8 Honors Bachelors Degree STEM
A minimum of 5 years of EU and US medical device regulatory affairs experience
Demonstrated experience assessing product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU such as 510(k)s and MDR Technical Documentation
Basic computer skills including experience with the software applications Microsoft Word Excel PowerPoint and Adobe Acrobat
Strong technical research and problem-solving skills
Ability to articulate complex ideas clearly both verbally and in writing
Team player with excellent interpersonal skills
Demonstrated ability to effectively manage multiple projects and priorities
Works well in fast-paced cross-functional team environments

As a leader in medical science for more than 40 years we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives create value for our customers and support our employees and the communities in which we operate. Now more than ever we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So choosing a career with Boston Scientific isnt just business its personal. And if youre a natural problem-solver with the imagination determination and spirit to make a meaningful difference to people worldwide we encourage you to apply and look forward to connecting with you!

To search and apply for open positions visit: 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 .

Required Experience:

Manager

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. Wi...