Hybrid Regulatory Affairs Leader - Medical Devices

Oncology Voice Network LLC; Maple Grove (MN); Hybrid; USD 102,000 - 194,000; Full time

Benefits offered by this job

Health insurance

Job summary

Boston Scientific in Maple Grove, MN is seeking a Principal Regulatory Affairs Specialist to support post-market regulatory activities in interventional oncology. You will oversee PIRs, CAPAs, recalls, audits, and NCEPs, collaborating with global regulatory partners to ensure compliance and continuous improvement.

The role requires a strong regulatory background in medical devices, US and EU knowledge, and the ability to train teams on compliance in a fast-paced, hybrid work setting.

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• Minimum of 5 years' experience in Regulatory Affairs and/or Quality within the medical device industry, including 3+ years in Regulatory Affairs.
• Knowledge of US regulatory requirements; EU MDR and global regs.

Responsibilities

• Serve as Regulatory Affairs specialist and collaborate with Field Action Team on recalls and corrections.
• Manage communications with internal regulatory partners outside the U.S. and external bodies on recalls.
• Coordinate and manage PIRs, including investigation, documentation and reporting to regulators.
• Develop and monitor CAPAs to address nonconformances and drive improvement.
• Support regulatory activities for internal and external audits.
• Stay current on regulatory changes and communicate to stakeholders.
• Provide regulatory guidance to cross-functional teams and deliver training on compliance.

Skills

Regulatory expertise

Microsoft Office

Adobe Acrobat

Document control systems

Quality management software

AI tools usage

Technical writing

Education

Bachelor's degree in scientific/technical discipline

Advanced degree (preferred)

Tools

AI tools

Regulatory databases

Job description

Boston Scientific in Maple Grove, MN is seeking a Principal Regulatory Affairs Specialist to support post-market regulatory activities in interventional oncology. You will oversee PIRs, CAPAs, recalls, audits, and NCEPs, collaborating with global regulatory partners to ensure compliance and continuous improvement.

The role requires a strong regulatory background in medical devices, US and EU knowledge, and the ability to train teams on compliance in a fast-paced, hybrid work setting.