Key Areas of Responsibility:
Anticipates regulatory risks and emerging issues, offering proactive, solutionsoriented guidance throughout the product lifecycle.
- Translates regulatory intelligence into actionable local, regional, and global regulatory strategies aligned with business goals.
Evaluates products for classification, jurisdiction, and marketaccess requirements, identifying the most efficient regulatory pathways.
Provides technical regulatory input across quality, preclinical, clinical, and manufacturing teams to ensure compliance.
Leads regulatory submissions endtoendplanning, preparing, submitting, and managing interactions with global health authorities.
Reviews scientific documentation (quality, preclinical, clinical) for completeness, accuracy, and regulatory acceptability.
Collaborates effectively with cross-functional teams, supporting meetings with regulatory authorities and advisory committees.
Develops and enhances regulatory SOPs, strengthens compliance, and
trains stakeholders on evolving regulatory expectations.
Manages complex regulatory projects with autonomy, strong organization, and sound decisionmaking.
Demonstrates inclusive leadership, embracing diverse perspectives and supporting the development of Specialists/Sr. Specialists.
Adapts to challenging assignments, navigates organizational dynamics, and continuously builds regulatory expertise.
Qualifications
- Bachelor's degree in Engineering, Science, or related field; Master's in Regulatory Science preferred
- 4+ years of regulatory affairs experience in healthcare, medtech, pharma, or related regulated industries
- Regulatory Affairs Certification (RAC) is a plus
- Strong understanding of regulatory pathways, compliance, submissions, quality systems, and postmarket requirements
- Excellent communication, technical writing, and project management skills
- Ability to operate with autonomy, judgment, and crossfunctional influence
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
