Senior Regulatory Affairs Specialist

2 weeks ago

Cork, Cork, Ireland Boston Scientific Full time

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 three Irish sites.
Ireland-Cork; Ireland-Clonmel; Ireland-Galway
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.This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Cork, Galway or Clonmel.
You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
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
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: Required: 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 the software applications 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 an advantage 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 .

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