Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

What you will be doing:

• 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

Who are we looking for:

• BS in Engineering, Science, or related degree; or MS in Regulatory Science

• 0+ yrs experience

• Time management skills, writing, coordination, and execution of basic regulatory items

• Coordinate and support technical and scientific regulatory activities

• Under supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility

• Some evaluation, originality or ingenuity is required

• Clearly conveys information to peers, supervisors, and other stakeholders

• Assists in the preparation for meetings with regulatory agencies and other stakeholders

• Assists 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

• Seeks out diverse ideas, opinions, and insights, and applies them in the workplace

• Connects and relates well with people who think and act differently than oneself

• Embraces scrutiny and accepts feedback as opportunity to learn and improve

About Stryker

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 130 million patients annually. More information is available at stryker.com. (http:)

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.