Staff Regulatory Affairs Specialist (Labeling)

Stryker - Mahwah, NJ

Full-time
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Regulatory Affairs Specialist focused on Labeling to join our Joint Replacement division in Mahwah, New Jersey.

Who we want

Self-directed imitators. 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.
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.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As a Staff Regulatory Affairs Specialist in Labeling, you serve as the subject matter expert for medical device labeling regulatory requirements by applying your knowledge and understanding of the regulatory and legal frameworks, requirements, legislation, processes and procedures.

Responsibilities include:
Assess labeling regulatory requirements and recommend solutions and best practices for implementation of compliant labeling
Approve labeling content from a regulatory perspective (implant card, IFU, patient leaflet etc.)
Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature
Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
Assist in the development of regulatory strategy and update strategy based upon regulatory changes
Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
Compare regulatory outcomes with initial product concepts and recommend changes or refinements based on initial regulatory outcomes
Negotiate with regulatory authorities throughout the product lifecycle
Identify the need for new regulatory procedures, SOPs, and participate in development and implementation
Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
Assist other departments in the development of SOPs to ensure regulatory compliance
Provide regulatory input and technical guidance on global regulatory requirements to product development teams
Evaluate proposed labeling changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
Provide knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
Provide regulatory information and guidance for proposed product claims/labeling
Ensure clinical and non-clinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
Monitor the progress of the regulatory authority review process through appropriate communications with the agency
Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
Work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
Coordinate input, feedback, and represents their division's needs
Accountable for local process and training implementation including all Divisional business units and acquisitions in scope
Update the GPO and/or PMO on divisional deliverables and progress
Ensure the global initiatives in their area are communicated and understood by divisional stakeholders
Serve as the voice for their division in the process area
Engage in meetings, surveys, information gathering and decisions
Deliver against agreed project deadlines
Communicate to leadership and stakeholders throughout levels at their division/site

What you need

Bachelor’s degree required with Engineering, Biological Sciences or equivalent focus preferred
5+ years of Regulatory Affairs experience in an FDA regulated industry
Ability to understand and explain detailed regulatory compliance programs or issues
Ability to comply with constantly changing regulatory procedures and prioritize work effectively
Ability to analyze and resolve non-routine regulatory issues using independent judgement
Demonstrated analytical, writing and organizational skills
Demonstrated interpersonal, written and oral communication skills

You may also have

Experience working in an FDA regulated industry
Previous experience with Class II/Class III medical devices
Regulatory Affairs Certification (RAC) or advanced degree (Masters in Regulatory Affairs)

Work From Home: No

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.