As a
Senior Staff Regulatory Affairs Specialist (m/f/d),
you will act as a strategic partner and subject matter expert, driving regulatory strategy and execution for complex and innovative medical devices across global markets.
What You Will Do
* Lead the preparation, coordination, and submission of regulatory applications to support product approvals and maintenance in multiple international markets (EU MDR, FDA, and other key regions).
* Develop and implement global regulatory strategies to ensure timely market access while maintaining compliance with all applicable regulations.
* Partner closely with cross-functional teams (R&D, Quality, Manufacturing, Clinical, and Marketing) to provide regulatory input throughout the product lifecycle, from development to post-market support.
* Monitor, interpret, and communicate changes in global regulatory requirements and assess their impact on Stryker's products and processes.
* Prepare and review complex regulatory documentation, including technical files, design dossiers, and submissions.
* Represent Regulatory Affairs in audits, inspections, and interactions with competent authorities or regulatory bodies.
* Drive continuous improvement within Regulatory Affairs processes, tools, and systems to enhance quality and efficiency.
* Mentor and provide technical guidance to other Regulatory Affairs professionals, fostering a culture of learning and collaboration.
What you will need:
Required:
* Bachelor's or Master's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.
* Minimum of 7 years of experience in Regulatory Affairs within the medical device industry.
* Demonstrated expertise in international regulatory submissions and compliance (EU MDR, FDA 510(k)/PMA, or other global markets).
* Strong understanding of global medical device regulations, standards (ISO 13485, ISO 14971), and documentation requirements.
* Proven ability to manage complex projects, prioritize effectively, and meet deadlines in a dynamic environment.
* Excellent communication and interpersonal skills, with the ability to influence across levels.
* Fluent in English (written and spoken).
Preferred:
* Experience with product development and lifecycle management for complex or innovative devices.
* Knowledge of software as a medical device (SaMD) or digital health technologies.
* Additional language proficiency is a plus.
Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.
Additional Information
The position is limited to 3 years. Due to the large number of different positions and areas of responsibility, Stryker often offers the options of being taken on in a permanent position.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.