Senior Regulatory Affairs Specialist

Join Strykers Ortho Tech Division as a Sr Regulatory Affairs Specialist and support regulatory activities for products used across a broad portfolio of Orthopedic this role you will help maintain regulatory compliance support submission activities and provide regulatory intelligence that enables products to meet global market requirements. This is an excellent opportunity for an early-career professional to develop foundational regulatory affairs expertise while partnering with cross-functional teams in a highly regulated environment.

What You Will Do

• Monitor regulatory requirements guidance documents and industry standards across applicable global markets.

• Research and compile regulatory requirements approval pathways and compliance information for products and programs.

• Collect organize and maintain regulatory intelligence files submission documentation and supporting records.

• Assist in preparing regulatory dossiers pre-submission packages and submission materials for regulatory agencies.

• Track regulatory submissions and applications under review and provide status updates to stakeholders.

• Maintain records of communications commitments and outcomes with regulatory authorities and other stakeholders.

• Coordinate meeting logistics and develop supporting materials for discussions with regulatory agencies and internal teams.

• Organize and support the review of preclinical clinical quality and technical documentation used to meet regulatory requirements.

What You Will Need

Required Qualifications

• Bachelors degree required. Preferred to be in Engineering Science Regulatory Science or a related technical field with 6-10 years of work experience.

• Demonstrated ability to work with technical scientific or regulated documentation through academic internship co-op or professional experience.

Preferred Qualifications

• Masters degree in Regulatory Science or a related field.

• Experience supporting regulatory affairs quality clinical research or compliance activities in a regulated industry.

• Familiarity with medical device pharmaceutical biotechnology or other regulated industry regulations and standards.