What are the responsibilities and job description for the Senior Regulatory Affairs Specialist (Hybrid) position at Stryker Group?
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 Medical and Surgical, Neurotechnology, Orthopedics 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 Specialist to join our Endoscopy Division based Hybrid in San Jose, California.
Who we want
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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.
What you will do
As the Senior Regulatory Affairs Specialist , you will have an integral role in ensuring continued marketability of Stryker’s Surgical Support devices. You will support new product development and business development, authoring regulatory submissions and international registration deliverables for both the U.S. and global regions. You will update and review technical files, review and document design changes, support manufacturing and quality projects, and interact with regulatory agencies and notified bodies. The Senior Regulatory Affairs Specialist is the Regulatory SME on cross-functional teams and a key point of contact for internal partners.
Participate in product sustaining teams as the Regulatory SME to ensure that Stryker continues to satisfy US, EU, and global regulatory requirements.
Act as the Point of Contact for responsible products / technical files.
Author and submit electronic regulatory submissions for the FDA and Notified Body.
Prepare EU design dossiers / technical files and other related product documentation.
Work with the RA team, Stryker Global Technology Center, and cross-functional partners on base business support such as annual file updates, NC / CAPA, and audits.
Assist in developing regulatory strategy, approval pathways, and compliance activities.
Negotiate with regulatory authorities and notified bodies to ensure continued compliance and efficiency of reviews.
Track the status of applications under regulatory review, participate in interactive reviews, and provide updates to the regulatory and project teams.
Provide input to projects leads to help develop timelines, perform global regulatory impact assessments, and complete change tasks.
Support international submissions and international regulatory notifications.
Perform regulatory reviews for technical documents such as clinical documents, post-market surveillance reports, and NC / CAPA.
Maintain current product registrations and assist in processing registration changes when required.
Assist with the creation of regulatory procedures, work instructions, and updates to technical and QMS procedures.
What you need
Required
Bachelor's Degree in Engineering, Science, or related degree.
Minimum 2 years' experience in an FDA-regulated industry.
Time management skills, writing, coordination, and execution of basic regulatory items.
Preferred
Master's Degree in Regulatory Affairs or RAC certification preferred.
1-2 years of regulatory affairs experience within the medical device industry.
Knowledge of FDA and international medical device regulations and standards (e.g. EU MDR) preferred.
97,900.00 - $156,900.00 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.
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Remote working / work at home options are available for this role.
Salary : $97,900 - $156,900
