Hybrid Regulatory Affairs Specialist – MedTech & IVDs

Siemens Healthineers AG; Walpole (MA); Hybrid; USD 147,760 - 203,170; Full time

Benefits offered by this job

medical insurance

dental insurance

vision insurance

401(k) retirement plan

paid time off

Job summary

Siemens Healthineers AG is looking for a Regulatory Affairs Professional to join their team in Walpole, MA. This hybrid position entails preparing and maintaining regulatory submissions, collaborating with cross-functional teams, and providing training on regulatory requirements. The ideal candidate will have a Bachelor’s degree in a scientific discipline and at least 2 years of experience in IVDs or medical devices. Strong knowledge of US/EU regulations and good attention to detail are essential. Comprehensive benefits offered including medical and retirement plans.

Qualifications

• Minimum of 2 years of experience in IVDs or Medical devices.
• Experience of working in a GMP environment.
• Intercultural sensitivity and excellent organizational skills.

Responsibilities

• Prepare, submit, and maintain regulatory submissions.
• Serve as a Regulatory Affairs subject matter expert.
• Collaborate with cross-functional teams for compliance.

Skills

US/EU regulations knowledge

IVD products knowledge

Presentation skills

Attention to detail

Team orientation

Education

Bachelor’s degree in scientific discipline

Tools

Outlook

SharePoint

Adobe Acrobat

Microsoft Office

Azure DevOps

Job description

Siemens Healthineers AG is looking for a Regulatory Affairs Professional to join their team in Walpole, MA. This hybrid position entails preparing and maintaining regulatory submissions, collaborating with cross-functional teams, and providing training on regulatory requirements. The ideal candidate will have a Bachelor’s degree in a scientific discipline and at least 2 years of experience in IVDs or medical devices. Strong knowledge of US/EU regulations and good attention to detail are essential. Comprehensive benefits offered including medical and retirement plans.