Stryker Regulatory Affairs Specialist in San Jose, California
Who we want
Focus. Takes direction, follows through, and makes 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
As a key team member of our Sports Medicine new product development team, you’ll live our Stryker mission of Making Healthcare Better by being involved in providing new and innovative medical devices to our customers. Our Sports Medicine business is one of the smallest, yet fastest growing parts of Stryker, making it an exciting time to join our team and industry. Our passionate and motivated team is focused on innovation and quality, alongside a fast paced and results oriented environment.
The Regulatory Affairs Specialist’s primary function is to partner with our implant devices new product development teams to ensure that products remain compliant by interpreting regulations (both US and global) and internal procedures. The team then applies these interpretations through the product design life-cycle. This includes authoring documentation to support introduction of products to various markets and may include submission of less complex regulatory submissions to FDA, Notified Bodies and other regulatory bodies.
Develop basic knowledge and understanding of regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
Identifies information sources and resources for local, regional, and global regulations
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•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 (e.g. 510(k)s, Technical Files)
Assist in the review of advertising and promotional marketing collateral
Balance strategic thinking and strong analytical skills with ability to execute
Excellent verbal and written communication skills, tact, accuracy, and the ability to prioritize work
What you need
0-2 years of experience in a FDA regulated industry
Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related
Ability to understand and explain detailed regulatory compliance programs and/or issues
Ability to comply with constantly changing regulatory procedures and prioritize work effectively
Ability to analyze and resolve non-routine regulatory issues using independent judgment
Excellent analytical and writing skills
Effective interpersonal communication skills
Effective organizational skills
Excellent independent judgment skills
Work From Home: No
Travel Percentage: Up to 25%
Stryker Corporation is an equal opportunity employer. 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.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com