Manager, Regulatory Affairs – Global Strategy & Leadership

Stryker; Portage (MI); Hybrid; USD 127,000 - 211,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Stock Purchase Plan

Life insurance

Job summary

Stryker, Portage, Michigan, seeks a Manager, Regulatory Affairs for Surgical Technologies in a hybrid role based in Portage with three onsite days weekly. You will guide global regulatory strategy across the product lifecycle and partner with R&D, Clinical, Quality, Manufacturing, Marketing, and Commercial teams to integrate regulatory requirements into development plans.

This role leads regulatory processes, authority interactions, and team development in a complex global environment, balancing

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field.
• Minimum 6 years of experience in regulated industries (medical device/pharma/biotech).
• Experience preparing, reviewing, or overseeing regulatory submissions and authority interactions.
• People management experience or leading cross-functional programs.
• Experience with FDA, EU, and international regulatory requirements including ISO/Quality System standards.
• Fluency in English.

Responsibilities

• Lead, develop, and engage a high-performing regulatory team with clear priorities and development plans.
• Drive regulatory planning, translate evolving requirements into actionable market-access plans.
• Provide strategic regulatory guidance to R&D, Quality, Clinical, Manufacturing, and Commercial teams.
• Oversee regulatory submissions, registrations, agency interactions, inspections and audits.
• Lead interactions with global regulatory authorities, notified bodies, and industry groups.
• Monitor regulatory processes, escalate issues, and report metrics to identify risks and opportunities.
• Recruit, onboard, coach, and retain regulatory talent with accountability and development focus.
• Support regulatory advocacy, budgeting, forecasting, and strategic planning.
• Represent regulatory during audits and contribute to policy-shaping activities.

Skills

Regulatory leadership

Strategic planning

Cross-functional collaboration

People management

Regulatory submissions

FDA regulations

EU regulations

English fluent

Education

Bachelor’s in STEM

Master’s degree preferred

RAC certification

Job description

Stryker, Portage, Michigan, seeks a Manager, Regulatory Affairs for Surgical Technologies in a hybrid role based in Portage with three onsite days weekly. You will guide global regulatory strategy across the product lifecycle and partner with R&D, Clinical, Quality, Manufacturing, Marketing, and Commercial teams to integrate regulatory requirements into development plans.

This role leads regulatory processes, authority interactions, and team development in a complex global environment, balancing