Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
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Job Description
Stryker is hiring a Senior Regulatory Affairs Specialist to join our Sage business in Cary Illinois! In this role you will support product compliance and market access by applying your understanding of regulatory frameworks requirements and procedures throughout the product lifecycle.
What you will do:
Assesses regulatory intelligence to support the development and refinement of local regional and global regulatory strategies.
Evaluates the regulatory environment to provide guidance throughout the product lifecycle (concept to post-market) ensuring compliance and facilitating market access.
Anticipates and addresses regulatory obstacles and emerging issues by developing proactive solutions.
Determines regulatory classification jurisdiction and submission requirements (local national international) including approval pathways and compliance activities.
Provides regulatory input and technical guidance on quality preclinical clinical and manufacturing data to meet applicable standards.
Assesses the acceptability of documents for submission and evaluates proposed changes to determine regulatory impact and filing strategies.
Prepares and submits regulatory dossiers (electronic/paper) and monitors agency reviews through effective communication with authorities.
Advises cross-functional teams on regulatory requirements for claims labeling and market access (e.g. federal state/provincial reimbursement purchasing groups).
Leads or supports interactions with regulatory bodies including pre-approval inspections GCP inspections panel meetings and advisory committees.
Develops and implements regulatory SOPs and procedures; supports organizational compliance through training and cross-departmental collaboration.
Tracks and submits required reports/notifications during clinical research and ensures data supports regulatory strategy and product claims.
What you need:
Required:
Bachelors degree required. Preferred to be in Engineering ScienceLegal or related.
2 years of regulatory experience.
Preferred:
New product development (NPD) experience is a plus.
RAC(s) preferred.
Manages and executes regulatory projects including writing coordination and technical/scientific activities.
Demonstrates strong interpersonal skills by engaging diverse perspectives and fostering collaboration across teams.
Navigates organizational dynamics effectively balancing competing priorities and aligning actions with strategic goals.
Required Experience:
Senior IC
Employment Type
Full-Time
