Remote Senior Regulatory Affairs Specialist

Siemens Healthineers; Walpole (MA); On-site; USD 118,000 - 162,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid time off

Paid sick leave

Job summary

Siemens Healthineers in the United States is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and lifecycle documentation for medical devices and IVDs. You will serve as a regulatory expert, guide design control activities, and collaborate with product teams to ensure QMS alignment and compliance across US and EU markets.

You will prepare technical files, participate in audits, and provide training on country-specific requirements, with a focus on timely execution

Qualifications

• Bachelor’s degree in scientific discipline.
• Minimum of 4 years of experience in IVDs or Medical devices.
• Experience in GMP environment.
• Strong attention to detail and organizational skills.
• Ability to work cross-functionally and communicate effectively.

Responsibilities

• Prepare, submit, and maintain regulatory submissions and lifecycle documentation (FDA 510(k), IVDR, etc.).
• Serve as regulatory affairs expert guiding design control and new product development teams.
• Prepare, submit, and maintain Technical Files compliant with QMS.
• Collaborate with cross-functional teams to maintain quality guidelines and procedures.
• Lead/regulatory projects to ensure timely execution and alignment with strategy.
• Provide training on country-specific regulatory requirements.

Skills

Regulatory affairs

Cross-functional

Attention to detail

Communication skills

GMP knowledge

Education

Bachelor's degree in science

Tools

Outlook

SharePoint

Adobe Acrobat

Microsoft Office

Excel

Azure DevOps

Job description

Siemens Healthineers in the United States is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and lifecycle documentation for medical devices and IVDs. You will serve as a regulatory expert, guide design control activities, and collaborate with product teams to ensure QMS alignment and compliance across US and EU markets.

You will prepare technical files, participate in audits, and provide training on country-specific requirements, with a focus on timely execution