Regulatory Affairs Specialist

Quick Facts

• Regulatory Affairs Specialist focused on worldwide product registration and ongoing license maintenance for medical device technologies
• Onsite role based in Mounds View, MN

Description

Provide regulatory strategy/plans and worldwide compliance requirements for diagnostic products, programmers/programming software, and accessories for pacemakers and defibrillators, patient monitors, and software as a medical device. Assist with submissions and reports to regulatory agencies, negotiate approvals as needed, support currently marketed products including labeling and documentation changes, and maintain regulatory affairs product files to support compliance.

Role And Responsibilities

• Assist in preparing worldwide submissions for new products and their product changes to ensure timely approval for market release
• Review significant regulatory issues and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies
• Prepare regulatory strategies/plans and worldwide compliance requirements; provide on-going support to project teams
• Find, interpret, and apply regulations and guidance appropriately; communicate business and product information to project teams
• Provide regulatory support for currently marketed products: review labeling and changes to existing devices and documentation; prepare submissions and reports
• Apply technical/regulatory principles; negotiate with international agencies as needed
• Participate in project team meetings to plan regulatory strategies, including specifications, target market/distribution method, and testing requirements
• Provide regulatory analysis of product portfolio and align Diagnostics/EPG portfolio with existing portfolio; maintain regulatory affairs product files
• Work under general supervision following established procedures; independently determine and develop approach
• Keep current on global directives, harmonized standards, and procedures; communicate changes affecting cross-functional areas
• Provide training and support to other members of the department
• Other tasks as required

Requirements

• Bachelor’s degree in a technical discipline
• Minimum 2 years of medical device regulatory experience with a bachelor’s degree, OR minimum 0 years with an advanced degree

Nice to Have

• Experience in regulated biotechnology environment; involvement in regulatory submissions; interactions with regulatory agencies (e.g., FDA and PMDA); cross-functional project teams
• Master of Science degree
• In-depth experience with FDA requirements and guidance; Medical Device Directive; ISO 14971; ISO 13485; global regulatory requirements and quality standards
• Working knowledge of SaMD and SiMD
• Positive track record engaging with regulators; history of successful device submissions
• Strong negotiation skills; strong written/oral communication skills
• Strong organizational skills and time management; ability to multitask across multiple global projects and meet deadlines
• Ability to work independently and under general direction only
• Computer skills: MS Office, MS Project, Adobe Acrobat, Agile

Benefits & Compensation

• Competitive salary and flexible benefits package
• Short-term incentive: Medtronic Incentive Plan (MIP)
• U.S. salary range (excluding Puerto Rico and specific locations in California): $74,400.00 - $111,600.00
• Regular employee benefits for 20+ hours/week: health, dental and vision insurance; HSA; healthcare FSA; life insurance; long-term disability; dependent daycare spending account; tuition assistance/reimbursement; global well-being program
• Regular employee benefits for all regular employees: incentive plans; 401(k) with employer contribution and match; short-term disability; paid time off; paid holidays; employee stock purchase plan; employee assistance program; non-qualified retirement plan supplement; capital accumulation plan (for VPs and above, or subject to IRS earning minimums)
• Equal employment opportunity and reasonable accommodations for qualified individuals with disabilities