Associate Manager, Regulatory Affairs
- Amsterdam, Netherlands
About Stryker Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Responsible for leading regulatory team and activities in order to secure timely approvals, renewals and maintain market clearance with a primary focus on EMEA (Europe/Middle East/Africa), other regions as assigned.
Essential Duties & Responsibilities
Under general supervision of EMEA & LATAM Int'l Regulatory Affairs Senior Manager:
- Prepares complex submissions to gain approvals for commercial distribution, clinical research and export, such as: Clinical Trial Submissions [OUS], Technical/Design Dossiers, Certificates to Foreign Government. Ensures that existing approvals, renewal cycles and documentation are maintained, including SAP Foreign Trade Status. Communicates with in-country Regulatory Affairs personnel to facilitate global clearances/approvals.
- Develops and executes, within requisite timelines, global regulatory strategies for assigned regions. Provides input on and reviews on regulatory strategies to drive product introductions and support approval/license maintenance, protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies. Monitors, researches and obtains information clearances/approvals of competitors, and proactively shares this information with Strategic Planning Franchise Team.
- Communicates with regulatory agencies under the guidance of the Int'l Regulatory Affairs leadership. Identify Advocacy opportunities and plans and executes meetings with regulatory agencies and investigators accordingly.
- Mentors teams and others on a regular basis, enhancing career development while advancing talent in accordance to business and department needs and upcoming opportunities.
- Evaluates and approves proposed changes to products and controlled documents; develops, approves, and implements global regulatory action plans based on the changes. Organizes and maintains Regulatory Affairs files.
- Reviews and approves labeling (Instructions for Use, labels, promotional materials) for compliance to: standards, guidelines, regulations, and regulatory approvals/clearances.
- Provides regulatory support to other Stryker Personnel to facilitate cross-divisional leverage.
- Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions and SOPs as needed to support departmental functions and divisional Quality System. Prepares and delivers training programs to the department and other functional groups to ensure compliance.
- Understands: Stryker Neurovascular's systems, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, ISO 46000 series, labeling requirements, Quality System Regulation, export requirements, and regulatory requirements of pertinent regions. Monitors changes in the regulatory environment, evaluates impact, and communicates to interested parties.
- Uses existing project management tools and develops/improve new/existing tools as needed (i.e. RA Metrics, RA Intel database, etc.).
- Performs responsibilities required by the Quality System and other duties as assigned or requested.
- Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).
Education/Special Training Required
- Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline.
Qualifications/Work Experience Required
- Professional certification(s) preferred.
- A minimum of 7 years of Regulatory Affairs experience, with medical device industry experience preferred; 3 years supervisory experience preferred.
- Strong leadership, interpersonal and influencing skills; demonstrated ability to effectively engage and drive "Regulatory Advocacy" activities with global regulators.
- Demonstrated knowledge and application of regulatory requirements, including EU Medical Devices Directive, EU Medical Device Regulations, ISO 13485 post market surveillance requirements; strong preference for prior experience leading EEMEA pre- and post-market regulatory activities.
- Demonstrated success in management of international regulatory submissions activities.
- Thorough understanding of global regulations.
- Demonstrated ability to effectively prioritize and manage multiple project workloads.
- Solid technical knowledge of medical products, preferably neurovascular. In addition, technical understanding of relevant procedures, practices, and associated medical terminology.
- Knowledge of clinical trial strategy and study design to support product approvals.
- Excellent analytical skills.
- Experience with talent / team development
- Excellent written and oral communication, technical writing and editing skills.
- Proficiency with Microsoft Office.
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