Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.
Focus. Takes direction, follows through, and mak
es the corrections necessary to stay on track. Prioritizes then acts.
Achievers. Thrives on accomplishing tasks and constantly driven to do more. Collaborators. Collaborates and builds relationships with internal and external stakeholders.
Communicators. Articulates well and expresses ideas effectively.
Learners. Great desire to learn and looks to continuously improve.
Teammates. Supports, encourages, and inspires others.
What you will do
The Regulatory Affairs team supports new product development for both domestic and international market releases and provides regulatory oversight post market. They participate on cross functional teams to develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies and review labeling and marketing material during the pre-market phases. The Regulatory Affairs team also evaluates proposed design changes for both new products and sustaining products. They support the product lifecycle through obsolescence by assessing changes made to the device post launch to determine the regulatory impact to the current clearance/approval by all regulatory bodies.
Exposure to all types of single-use Class I and II products with an array of clinical applications.
Partner regularly with the engineers on the team compiling regulatory submissions.
Provide strategic direction on how to best streamline our process and use more of a risk-based approach to making decisions.
Learn about innovative reprocessing methods, testing and criteria.
What you need
Bachelor’s degree preferred in life science, engineering discipline or similar field
3 - 5 years’ experience in regulatory areas.
Extensive experience with FDA regulations and compliance.
Quality Assurance/Regulatory experience in class II medical devices.
Expertise with 510(k) submissions.
Ability to manage the regulatory functions, as well as involvement in key projects.
Ability to interface with both technical and non-technical personnel.
Ability to work effectively in a team environment with shifting priorities and timeliness requirements.
Possesses excellent interpersonal, analytic, and problem-solving skills.
Possesses strong interpersonal and persuasive skills.
Proficient in Microsoft Word, Excel, Power Point, Outlook.
Exposure to JD Edwards (One World) and Business Objects preferred.
Production / Cleanroom at times
May be exposed to Hazardous materials. Employees need to consult MSDS in their work area.
Required at times to wear Personal Protective Equipment to protect against exposure to Bloodborne pathogens and chemicals.
Internal Number: 29729BR
Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.