Overview
Join to apply for the Senior Regulatory Affairs Specialist role at Boston Scientific.
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 three Irish sites: Ireland-Cork; Ireland-Clonmel; Ireland-Galway. This is a hybrid position (in office minimum three days per week) with flexibility to be located in Cork, Galway or Clonmel.
Job Purpose
The Senior Regulatory Affairs (RA) Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. Additionally, the Senior RA Specialist is responsible for assessment of device changes for regulatory implications.
Key Responsibilities
* Develop US, EU and international regulatory strategies for approval of medical devices
* Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products
* Support requests from BSC International Regulatory personnel related to submissions, registrations, and change assessments
* Develop and maintain positive relationships with regulatory body reviewers
* Review Technical and Labelling documentation for inclusion in regulatory filings
* Review product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
* Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
* Review clinical study protocols and other clinical documentation, and assess clinical study related changes to determine regulatory impact
* Support regulatory audits, as required
* 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 minimum of a Level 8 Honours Bachelor's Degree in STEM
* A minimum of 5 years of regulatory affairs or related 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 Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Preferred
* 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
* Pharmaceutical and/or Drug/Device Combination device experience and Clinical expertise is an advantage
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 isn’t just business, it’s personal. If you’re 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 our careers page. Boston Scientific recognises that nurturing a diverse and inclusive workplace helps us be more innovative and is essential in advancing science for life and improving patient health. We are an equal opportunity and affirmative action employer and are committed to providing reasonable accommodations for applicants and employees with a disability. If you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com.
Note: This description reflects the current role and responsibilities and may be subject to change.
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