Senior Regulatory Affairs Specialist (Hybrid)
Apply
Locations: Redmond, Washington
Time Type: Full time
Posted on: Posted Today
Job Requisition ID: R526116
Work Flexibility: Hybrid
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 www.stryker.com.
We are currently seeking a Senior Regulatory Affairs Associate to join our Medical Division, Hybrid, to be based in Redmond, Washington.
Who We Want
- Self-directed imitators: People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- Strategic thinkers: People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
- Collaborative partners: People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
- Dedicated achievers: People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Goal-oriented developers: Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
What You Will Do
As part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the market and ensure ongoing compliance. In this role, you will:
- Support R&D, Marketing, and Manufacturing teams with regulatory assessments of proposed changes or product transfers.
- Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial, state, reimbursement, purchasing groups, etc.).
- Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.
- Evaluate proposed products for regulatory classification and jurisdiction.
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
- Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products.
- Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
- Monitor the progress of the regulatory authority review process through appropriate communications with the agency.
- Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools.
- Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions.
- Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process.
- Maintain current product registrations and assist to process registration changes when required.
- Provide regulatory information and guidance for proposed product claims/labeling.
- Build relationships and interface with cross-functional teams (Engineering, International RA, Manufacturing, Marketing, etc.) to ensure accurate, complete, and timely submission preparation.
- Assist with the creation and/or revision of quality system procedures and work instructions as related to role responsibilities.
- Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
- Perform other duties as assigned by manager.
What You Need
- A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.
- A minimum of 2 years of experience in an FDA or highly regulated industry required.
- A minimum of 1 – 2 years in a Regulatory Affairs role required.
- Previous experience with Class II/III medical devices preferred.
- Previous experience drafting 510(k)s preferred.
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
- Experience authoring regulatory submissions for product approval preferred.
- Experience interacting with regulatory agencies preferred.
- 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.
- Excellent interpersonal, written, and oral communication skills.
- Effective organizational skills.
- Advanced PC skills with proficiency in Microsoft Office Suite, including Excel.
Salary: $86,600.00 - 138,800.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Travel Percentage: 10%
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.
#J-18808-Ljbffr
