Associate Manager Post Market Surveillance (R453061)
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Who we want:
- Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
- Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.
- Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.
- Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.
What you will do:
- Develops and implements processes involved with maintaining annual licenses, registrations, and listings
- Reviews and approves advertising and promotion to ensure regulatory compliance
- Assures post-market regulatory requirements are met
- Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
- Participates in implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g. HCP, patient, distributor, and health authorities)
- Reports product safety issues to regulatory authorities as required, to comply with local, regional, and global regulations
- Provides regulatory input and appropriate follow-up for inspections and audits
- Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
- Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
- Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
- Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
- Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
- Evaluates proposed products for regulatory classification and jurisdiction
- Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
- Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
- Negotiates with regulatory authorities throughout the product lifecycle
- Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
- Assists other departments in the development of SOPs to ensure regulatory compliance
What you need:
- BS in a science, engineering or related degree; Advanced degree preferred
- Minimum of 6 years’ experience; 3 years' supervisory experience preferred
- Master's Degree or equivalent preferred; RAC preferred
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.