Regulatory Affairs Specialist - New Product Development (Hybrid) - New Jersey, Mahwah 325 Corporate Dr

Work Flexibility: Hybrid or Onsite

We are currently seeking a 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 Regulatory Affairs Specialist, you will work with some supervision to bring new medical devices to market and ensures ongoing compliance. You will participate on cross-functional teams to develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes. You will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

• You will participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process.

• You will evaluate proposed products for regulatory classification and jurisdiction.

• You will evaluate medical device regulations and develop strategies for bringing products to market.

• You will provide regulatory input and technical guidance on global regulatory requirements to product development teams.

• You will anticipate regulatory obstacles and emerging issues and develops solutions and regulatory strategy accordingly.

• You will assist in the development of regulatory strategy and updates strategy based upon regulatory changes.

• You will assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.

• You will author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market.

• You will partner with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.

• You will assess global impact of changes to launched products and support notifications/submissions as required.

• You will review labeling and marketing literature for compliance with regulatory requirements.

• You will possess and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to bring products to market and maintain compliance.

• You will author and update divisional SOPs, recommends timely changes to ensure regulatory compliance, and leads process improvements to maximize efficiencies.

• You will provide regulatory information and guidance for proposed product claims/labeling.

• You will ensure the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.

• You will prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.

• You will monitor the progress of the regulatory authority review process through appropriate communications with the agencies.

• You will communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.

• You will work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.

• You will identify the need for new regulatory procedures, SOPs, and participates in development and implementation.

• You will advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.

What you need

• Bachelor’s Degree required; engineering or science degree is preferred.

• 0+ 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.

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.