Global Regulatory Affairs Specialist, Medical Devices

Coloplast; Minneapolis (MN); On-site; USD 107,000 - 161,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Flexible work options

Professional development

Recognition programs

Community & culture

Competitive compensation

Job summary

Coloplast is seeking a Regulatory Affairs Specialist to manage day-to-day regulatory tasks for medical devices across assigned geographies. You will prepare submissions, monitor status, and support post-market surveillance, change analysis, and vigilance reporting while ensuring design history file documentation stays current.

The role requires 3+ years in regulatory affairs within the medical device industry, familiarity with FDA and EU regulations, and CE marking/Health Canada experience is a

Qualifications

• BA/BS in scientific field or equivalent experience.
• 3+ years regulatory affairs in Medical Device industry.
• Familiarity with FDA and EU regulations for medical devices; CE marking and Health Canada experience preferred.
• Experience with FDA interactions and recalls/adverse event reporting desirable.

Responsibilities

• Coordinate compilation of regulatory submissions to expedite clearance/approval.
• Ensure design history file is current and review change controls.
• Prepare post-market surveillance data and CAPA investigations.
• Assist with regulatory strategy development and audits with regulatory bodies.

Skills

Regulatory affairs

Cross-functional teamwork

Analytical mindset

Attention to detail

Communication skills

Microsoft Office

Education

BA/BS in scientific field

Tools

Microsoft Office

Job description

Coloplast is seeking a Regulatory Affairs Specialist to manage day-to-day regulatory tasks for medical devices across assigned geographies. You will prepare submissions, monitor status, and support post-market surveillance, change analysis, and vigilance reporting while ensuring design history file documentation stays current.

The role requires 3+ years in regulatory affairs within the medical device industry, familiarity with FDA and EU regulations, and CE marking/Health Canada experience is a