Senior Regulatory Affairs Specialist
At Boston Scientific, we offer the opportunity to work in diverse and high-performing teams tackling important health industry challenges.
Job Purpose:
The Senior Regulatory Affairs Specialist is responsible for activities leading to and maintaining regulatory approval to market devices. This hybrid position involves a minimum of three days per week in the office, with flexibility to be located in Cork, Galway, or Clonmel.
Main Responsibilities:
* Develop US, EU, and international regulatory strategies for device approval.
* Coordinate 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.
* Maintain positive relationships with regulatory body reviewers.
* Review technical and labelling documentation for inclusion in regulatory filings.
* Assess product and manufacturing changes for compliance with applicable regulations and impact on regulatory filings.
* Represent RA on cross-functional projects, including product development, sustaining changes, and continuous improvement efforts.
* Review clinical study protocols and other clinical documentation, assessing clinical study-related changes for regulatory impact.
* Support regulatory audits as required.
* Prioritize patient safety and product quality by maintaining compliance with the Quality Policy and documented quality processes and procedures.
Education and Experience:
* A minimum of a Level 8 Honours Bachelor's Degree (240 credits) 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 on regulatory filings.
* Demonstrated experience authoring/supporting various regulatory submissions for US and EU, such as 510(k)s and MDR Technical Documentation.
* Basic computer skills, including Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
Preferred Qualifications:
* Strong technical, research, and problem-solving skills.
* Ability to articulate complex ideas clearly verbally and in writing.
* Team player with excellent interpersonal skills.
* Demonstrated ability to effectively manage multiple projects and priorities.
* Familiarity with fast-paced cross-functional team environments.
* Pharmaceutical and/or drug/device combination device experience and clinical expertise are advantageous.