Senior Regulatory Affairs Specialist — Medical Devices

Regulatory Jobs; New Brighton (MN); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Excellent retirement savings plan with

Tuition reimbursement and educationBEN

Abbott education benefits

Job summary

Abbott in New Brighton, MN is seeking a Senior Regulatory Affairs Specialist to support the regulatory department, ensuring compliant processes and effective data presentation for worldwide registrations. The role emphasizes collaboration across functions and a focus on post-market changes.

You will prepare and submit documentation, oversee regulatory filings, and maintain licenses with international affiliates. Excellent technical writing and negotiation with authorities are essential.

Qualifications

• Bachelor’s Degree or equivalent
• 3-4 years in a regulated industry (medical products, nutritionals)
• 2-3 years in regulatory preferred but can include QA, R&D/support, or related areas
• Strong written and verbal communication with internal/external regulators
• Ability to work in a highly matrixed, geographically diverse environment
• Knowledge of regulatory strategy development with supervision
• Experience with submission requirements, risk analysis, and data needs

Responsibilities

• Assist in SOP development and regulatory input to product lifecycle planning
• Develop regional regulatory strategy and update it with regulatory changes
• Assess regulatory implications of class/therapeutic contexts and communicate requirements
• Monitor regulatory submissions and interact with authorities during development
• Maintain licenses, registrations, listings, and post-market approvals
• Draft US/EU post-market change submissions and responses
• Review change controls and assess impact on submissions
• Contribute to crisis/issue management and regulatory recalls
• Handle areas like medical writing, labeling, import/export, and country-specific support

Skills

Regulatory compliance

Regulatory strategy

Regulatory writing

Cross-functional collaboration

Verbal & written communication

Education

Bachelor’s Degree

Master’s Degree in Regulatory Affairs preferred

Job description

Abbott in New Brighton, MN is seeking a Senior Regulatory Affairs Specialist to support the regulatory department, ensuring compliant processes and effective data presentation for worldwide registrations. The role emphasizes collaboration across functions and a focus on post-market changes.

You will prepare and submit documentation, oversee regulatory filings, and maintain licenses with international affiliates. Excellent technical writing and negotiation with authorities are essential.