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 Specialist to join our Joint Replacement Division to be based in Mahwah, NJ or Fort Lauderdale, FL or remotely anywhere in the United States.
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 Staff Regulatory Affairs Specialist, you will work with minimal supervision to bring medical devices to market and ensures ongoing compliance. You will mentor junior colleagues in the development of their regulatory skills. You will participate on cross-functional teams, develops global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews labeling and marketing materials, and evaluates proposed device changes. You will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
- 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.
- Evaluates proposed products for regulatory classification and jurisdiction
- Evaluate medical device regulations and develop strategies for bringing products to market.
- Provide regulatory input and technical guidance on global regulatory requirements to product development teams
- Anticipates regulatory obstacles and emerging issues and develops solutions and regulatory strategy accordingly
- Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
- Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
- Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market.
- Partner with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.
- Assess global impact of changes to launched products and support notifications/submissions as required.
- Reviews labeling and marketing literature for compliance with regulatory requirements.
- 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.
- Author and update divisional SOPs, recommends timely changes to ensure regulatory compliance, and leads process improvements to maximize efficiencies.
- Provide regulatory information and guidance for proposed product claims/labeling
- Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
- Prepare and submits 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
- Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
- Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.
- Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
What you need
- A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
- A minimum of 5 years of experience in an FDA regulated industry required; preferably with medical devices.
- A minimum of 3 years 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 required.
- 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.
- Excellent analytical and writing skills.
- Excellent interpersonal, written and oral communication skills.
- Effective organizational skills.
- Advanced PC skills with proficiency in Microsoft office Suite, including Excel.
Work From Home: Remote
Travel Percentage: Up to 25%
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.
Process Improvements (Business)