MedTech Regulatory Strategy Lead

Jobtailor; Lake Zurich (IL); On-site; USD 140,000 - 180,000; Full time

Job summary

Jobtailor is seeking an experienced Senior Regulatory Affairs professional to own regulatory decision-making and strategy for complex product lines and initiatives. You will lead regulatory submissions, coordinate responses, and align worldwide strategies with business objectives.

The role requires 8+ years in regulatory functions, strong communication with agencies, post-market compliance, and mentoring of team members. English proficiency is essential, and visa sponsorship is not available.

Qualifications

• Bachelor's degree required with 8+ years of regulatory experience.
• Experience in device and/or drug regulatory submissions and strategies.
• Ability to speak and write English; visa sponsorship not available.

Responsibilities

• Own regulatory decision-making and strategy for assigned product lines or initiatives.
• Prepare and oversee regulatory submissions and responses to agency questions.
• Lead health authority interactions and align global strategies with business objectives.
• Review product labeling and advertising/promotional materials for regulatory compliance.
• Mentor and train regulatory team members.
• Ensure post-market regulatory compliance, including PMS/PMCF reporting where applicable.
• Develop relationships with regulatory agencies and stakeholders.
• Represent Regulatory on product/project teams so strategies align with business goals.

Skills

Regulatory Decision-Making

Regulatory Submissions

Regulatory Compliance

Problem-Solving Skills

Understanding of Regulatory Requires

Complex Regulatory Strategies

Post-Market Regulatory Compliance

Health Authority Interactions

Product Labeling Review

Technical Oversight

Education

Bachelor's Degree

Job description

Jobtailor is seeking an experienced Senior Regulatory Affairs professional to own regulatory decision-making and strategy for complex product lines and initiatives. You will lead regulatory submissions, coordinate responses, and align worldwide strategies with business objectives.

The role requires 8+ years in regulatory functions, strong communication with agencies, post-market compliance, and mentoring of team members. English proficiency is essential, and visa sponsorship is not available.