Boston Scientific Regulatory Affairs Specialist II 

Ireland, Cork 

929444705

• Location: Cork
• Contract Type: Permanent
• Reporting to: Senior Manager, Regulatory Affairs
• Closing Date: 15th August

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.

Responsible for Regulatory Affairs support of the product sustaining process, submissions, maintenance of regulatory files and regulatory compliance.

Responsibilities

• regulatoryactivities at Boston Scientific.
• Supportmanufacturing and designsustaining activitiesby assessing regulatory impact of the change, and provide guidanceonregulatory strategies.
• Review and approve documentation related to product changes through the change notification process.
• Preparationand maintenanceof Technical Documentation.
• Preparation ofsubmissions such as Annual Reports, 30 Day notices, Notice of Change etc.
• SupportCork Quality functionduring external agency audits.
• Provide regulatory support for Cork Site projects
• Support strategy and submission activities for new product development

Qualifications & Experience

• Degree in Engineering or Life sciences (e.g., Chemistry, Biology, etc.).
• Medical device regulatory experience desirable
• Demonstrated execution and organizational skills.
• Demonstrated ability to handle multiple projects.
• Excellent verbal and written communication skills.
• Work successfully within a team environment and as an individual contributor.
• Flexible and ability to adapt to changing regulatory environment and business needs.
• Proficient use of technology including MS office programs

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people lives around the world. This is a place where you can find a career with meaningful purpose – improving lives through your life’s work.

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.