Mahwah, NJ, United States
Apr 09, 2021
Jul 23, 2021
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. 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 Trauma Division to be based in Mahwah, NJ or remotely anywhere in the United States.
Who we want
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
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.
What you will do
As a Senior Regulatory Affairs Specialist, you support new product development for both the US and OUS global regulatory release by contributing to the development and updating or regulatory strategy based upon regulatory changes. You support the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. You also ensure regulatory compliance by completing through assessments and the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies and other regulatory bodies. You are viewed as a regulatory team resource.
Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
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.).
Assists in the development of regulatory strategy and updates strategy based upon regulatory changes.
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
A minimum of a Bachelor’s degree required; Degree in Engineering, Life Sciences or similar preferred.
A minimum 3 years of experience in an FDA regulated industry required; preferably within medical devices
A minimum 2 year of Regulatory Affairs experience required.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
General understanding of product development process and design control.
General understanding of regulations applicable to the conduct of clinical trials.
Thorough understanding of FDA, Europe and international medical device regulations.
Previous experience with Class II/III medical devices preferred.
Previous experience drafting 510(k)s preferred.
Experience drafting 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.
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. (https://careers.stryker.com/referrals/)
Website : http://www.stryker.com