Why RA/QA at Stryker?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-teamWe are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.comStryker 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.comWe are currently seeking a Staff Regulatory Affairs Specialist to join our Endoscopy Division based Hybrid in Fremont, California.Who we want
Self-directed initiators. 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.
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 doAs the Staff Regulatory Affairs Specialist, you will work to maintain medical devices on the market and ensure ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interacts with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluates proposed device changes.Under general supervision of the RA Project Manager or RA Department Manager or Director.
Prepares complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMA Annual Report, HDE, HDE Annual Report, Shonin, PLA, CE-Mark Technical Documentation Design Dossier, CE-Mark Technical File, Intercontinental Dossiers, Certificates to Foreign Government. Ensures that existing approvals and documentation are maintained. Communicates with in-country RA personnel to facilitate global clearances/approvals.
Develops global regulatory strategies for project teams. Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies. Monitors, researches and obtains information [via FOI] on FDA clearances/approvals of competitors, and proactively shares this information.
For new, routine or ongoing issues, communicates with regulatory agencies. Prepares for meetings with regulatory agencies and investigators.
Provides promotional regulatory input on strategies and draft materials to help ensure promotional materials are aligned with global promotional regulations, corporate standards and policies and business objectives.
Reviews and approves advertising and promotional materials for division's product portfolio in accordance with current regulations and industry trends.
Mentors' others on a regular basis. Is not expected to supervise others.
Evaluates and approves proposed changes to products and controlled documents; develops, approves, and implements global regulatory action plans based on the changes. Organizes and maintains RA files.
Reviews and approves labeling (Instructions for Use, labels, promotional materials) for compliance to: standards, guidelines, regulations, and regulatory approvals/clearances.
Provides regulatory support to other Stryker personnel to facilitate cross-divisional leverage.
Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions, SOPs, and SLPs as needed to support departmental functions and Stryker's Quality System. Prepares and delivers training programs to the department and other functional groups to ensure compliance.
Understands: Stryker's systems, biocompatibility requirements, CMDRs, Design Control, Medical Device Directive, Essential Requirements, ISO 13485 , labeling requirements, Quality System Regulation, export requirements, and regulatory requirements of pertinent regions. Monitors changes in the regulatory environment, evaluates impact, and communicates to interested parties.
Uses existing project management tools, and develops/implements new tools as needed.
Performs responsibilities required by the Quality System and other duties as assigned or requested.
What you need
A Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
5+ years of experience in an FDA regulated industry required, preferably with medical devices.
2-3 years of Medical Device Regulatory Affairs experience required.
Previous experience drafting 510(k) regulatory submissions to FDA required.
Previous experience with Class II/III medical devices required.
Experience interacting with regulatory agencies required.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
Thorough understanding of FDA and international medical device regulations.
General understanding of product development process and design control.
Strong project management, writing, coordination, and execution of regulatory items.
Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.
About StrykerOur benefits:
12 paid holidays annually
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits (https://cdn-static.findly.com/wp-content/uploads/sites/1427/2023/09/20143933/us-stryker-employee-benefits.pdf)About StrykerStryker 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:)Know someone at Stryker?Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page (https://careers.stryker.com/referrals/)Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.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.
