Boston Scientific Global Regulatory Operations Specialist II 

United States, Minnesota, Arden Hills 

962645070

US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove; US-MN-Minnetonka

About the role:

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills, Maple Grove, or Minnetonka, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include:

• Support sterilization process owner and global regulatory processes, responsibilities include the following:
• 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 all Sterilization Subject Matter Experts (SMEs), Global Regulatory Affairs Operations team members, sterilization project members, and periodically with Divisional and/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

Required Qualifications:

• Bachelor’s Degree or equivalent work experience
• Minimum of 2 years’ experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, pharmaceutical or health care industry

Preferred Qualifications:

• 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)

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.