
Senior Product Risk Specialist
Are you a highly analytical and detail-oriented individual with a passion for product risk management? Do you have experience in the medical device industry and a strong understanding of global regulations and standards? If so, we have an exciting opportunity for you! Boston Scientific is seeking a Senior Product Risk Specialist to join our dynamic team. As a Senior Product Risk Specialist, you will play a critical role in ensuring the safety and quality of our innovative medical devices. Your expertise and knowledge will help drive our products to market while maintaining compliance with regulatory requirements. If you are ready to make a difference and take your career to the next level, we would love to hear from you!
- Conduct risk assessments for new and existing medical device products, identifying potential hazards and implementing risk mitigation strategies.
- Develop and maintain risk management processes and procedures in accordance with global regulations and standards.
- Collaborate with cross-functional teams to ensure that risk management is integrated throughout the product development and manufacturing processes.
- Monitor and analyze changes in regulatory requirements and communicate any potential impact on product risk management to relevant stakeholders.
- Provide guidance and training to team members on risk management principles and practices.
- Maintain and update risk management documentation, including risk management plans, hazard analysis, and risk management reports.
- Participate in product design reviews to identify potential risks and provide recommendations for risk reduction.
- Conduct audits and assessments to ensure compliance with risk management requirements.
- Serve as a subject matter expert on risk management, providing support and guidance to other departments as needed.
- Continuously evaluate and improve risk management processes to meet business needs and regulatory requirements.
- Communicate risk management updates and progress to management and other stakeholders.
- Collaborate with external partners, such as regulatory agencies and notified bodies, on risk management-related issues.
- Stay informed about industry trends and developments related to risk management and incorporate them into the company's practices.
- Mentor and train junior risk management team members to develop their skills and expertise.
Minimum Of 5 Years Of Experience In Product Risk Management Or Related Field.
Expert Knowledge Of Iso 14971 And Other Relevant Regulatory Standards For Medical Devices.
Strong Understanding Of Product Development Processes And Risk Management Methodologies.
Excellent Analytical And Problem-Solving Skills With The Ability To Identify And Mitigate Potential Risks.
Proven Track Record Of Successfully Leading Cross-Functional Teams And Driving Risk Management Strategies Within A Medical Device Company.
Product Development
Quality Assurance
Change Management
Process Improvement
Project Management
Data Analysis
Communication
Compliance Management
Risk assessment
Risk Mitigation
Cross-Functional Collaboration
Regulatory Affairs
Communication
Conflict Resolution
Leadership
Time management
creativity
Organization
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Senior Product Risk Specialist in Marlborough, MA, USA is $95,000 - $115,000 per year. This range can vary based on factors such as experience, education, and the specific company or industry the individual is working in.
Apply with Video Cover Letter Add a warm greeting to your application and stand out!
Boston Scientific Corp. engages in the development, manufacture and marketing of medical devices that are used in interventional medical specialties. Its products and technologies are used to diagnose or treat medical conditions, including heart, digestive, pulmonary, vascular, urological, women's health and chronic pain conditions.

Get interviewed today!
JobzMall is the world‘ s largest video talent marketplace.It‘s ultrafast, fun, and human.
Get Started
