Global Regulatory Operations Specialist II

Boston Scientific - Arden Hills, MN

Full-time - Mid Level

Hybrid - Arden Hills, MN

Miscellaneous Manufacturing

About the position

The Global Regulatory Operations Specialist II at Boston Scientific plays a crucial role in supporting sterilization processes and regulatory strategies within a dynamic global environment. This position involves collaboration with various teams to ensure compliance with regulatory requirements for Ethylene Oxide (EO) sterilization initiatives, including authoring submissions and managing standard operating procedures. The role is hybrid, allowing flexibility in work location while requiring a minimum of three days in the office.

Responsibilities

• Support sterilization process owner and global regulatory processes.
• Support regulatory strategy to gain approval for Ethylene Oxide (EO) sterilization initiatives.
• Author and submit EU MDR and US submissions for EO sterilization changes.
• Support and draft EU sterilization Notified Body (NB) questions and correspondence.
• Regular interaction with Sterilization Subject Matter Experts (SMEs), Global Regulatory Affairs Operations team members, and Divisional or Country Regulatory Affairs representatives.
• Own regulatory Standard Operating Procedures (SOPs) and Work Instructions (WIs) applicable to this role.
• Operate effectively as regulatory team lead on assigned projects.
• Support global regulatory projects/initiatives as needed.

Requirements

• Bachelor's Degree or equivalent work experience.
• Minimum of 2 years' experience in Regulatory Affairs or a related discipline within the medical device, pharmaceutical or health care industry.

Nice-to-haves

• Degree or work experience in a scientific or technical discipline.
• Experience with EO sterilization methods and processes.
• Excellent written and oral communication, technical writing and editing skills.
• Excellent research and analytical skills.
• Ability to support multiple projects simultaneously.
• Working knowledge of FDA, EU and/or international medical device regulations.
• Ability to read and interpret global regulations and standards.
• Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint).

Benefits

• Competitive salary
• Access to the latest tools and training
• Opportunities for career advancement
• Supportive work environment for personal and professional growth