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 Senior Staff Regulatory Affairs Specialist to join our Joint Replacement Division to be in Mahwah, NJ or remotely anywhere in the US.
Who we want
- Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop atnothing to ensure a project is complete and meets regulations and expectations.
- Communicators. Articulates well and expresses ideas effectively.
- Learners. Great desire to learn and looks to continuously improve.
- Teammates. Supports, encourages, and inspires others.
What you will do
As the Senior Staff Regulatory Affairs Specialist, you will bring and sustain products on the market via pre-market submission activities with global Health Authorities. You will operate in a fast-paced environment and you will liaise with internal and external customers and establish strong relationships with Health Authorities. You will translate complex engineering or scientific principles into approachable content while educating others on Stryker products and processes. You will provide leadership and guidance to junior Regulatory Affairs professionals.
- Possess and apply advanced knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to bring products to market and maintain compliance.
- Review progress with management; assist Management in training RA Specialists, Senior, or Staff Specialists as required.
- 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.
- Evaluate proposed products for regulatory classification and jurisdiction.
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
- Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
- Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
- Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to maximize efficiencies.
- Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
- 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.
- Demonstrate developing technical leadership skills interdepartmentally.
- Evaluate medical device regulations and develop strategies for bringing products to market.
- 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 Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support.
- Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Provide regulatory information and guidance for proposed product claims/labeling.
- 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.
- Assess global impact of changes to launched products and support notifications/submissions as required.
- Review labeling and marketing literature for compliance with regulatory requirements.
What you need
- A Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
- A minimum of 7 years of experience in an FDA regulated industry required.
- A minimum of 5 years of Regulatory Affairs experience required.
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
- Experience authoring regulatory submissions for product approval and interacting withregulatory agencies required.
- Proven ability to develop, author and implement global regulatory strategies for new products.
- Ability to comply with constantly changing regulatory procedures and prioritize workeffectively.
- 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: YesTravel Percentage: Up to 25%