Senior Regulatory Affairs Specialist (Hybrid)
Onsite
Mahwah, NJ, United States
Mahwah, NJ, United States
Posted 19 days ago
Job Details
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.
- 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
- 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.
- 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.
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