Job Information
Stryker Senior Regulatory Affairs Specialist (Hybrid) in Mahwah, New Jersey
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-team
We 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.com
We are currently seeking a Senior Regulatory Affairs Specialist to join our Joint Replacement Division based hybrid two days per week in Mahwah, NJ.
Who we want
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
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.
Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What you will do
As the Senior R egulatory Affairs Specialist , you will evaluate the regulatory environment providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance. You will assist in the development of regulatory strategy and update strategy based upon regulatory changes.
Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
Evaluates proposed products for regulatory classification and jurisdiction
Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
Negotiates with regulatory authorities throughout the product lifecycle
Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
Assists other departments in the development of SOPs to ensure regulatory compliance
Provides regulatory input and technical guidance on global regulatory requirements to product development teams
Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
Provides regulatory information and guidance for proposed product claims/labeling
Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
Monitors the progress of the regulatory authority review process through appropriate communications with the agency
Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
What you need
Bachelor's Degree required; engineering or science degree is preferred.
2+ years of experience in an FDA regulated industry required; preferably within medical devices.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
Medical device regulatory experience preferred.
General understanding of product development process and design control.
General understanding of regulations applicable to the conduct of clinical trials.
Familiarity with FDA, Europe and international medical device regulations.
About Stryker
Our 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 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:)
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.
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