Senior Regulatory Specialist

Job Description

What You Will Do - Identifies information sources and resources for local, regional, and global regulations Collects, organizes, and maintains files on local, regional, and global regulatory intelligence and other related information Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) Provides information used to evaluate proposed products for regulatory classification and jurisdiction Researches requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities Assists in the development of regulatory procedures and SOPs Collects and organizes information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations Organizes materials from preclinical and clinical studies for review and assists in the review process Compiles and organizes materials for pre-submission reports and communications Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies Tracks the status of applications under regulatory review and provides updates to the regulatory team Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings What You Will Need- Education / Work Experience: BS in Engineering, Science, or related degree; or MS in Regulatory Science 4 + yrs experience Knowledge / Competencies: Time management skills, writing, coordination, and execution of basic regulatory items Clearly conveys information to peers, supervisors, and other stakeholders Assists in the preparation for meetings with regulatory agencies and other stakeholders; in the preparation of briefings and other information documents Communicates information on regulatory requirements to other departments and business units Composes routine communications with regulators and other key stakeholders Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization 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. Show more Show less