Boston Scientific

Senior Product Risk Specialist

Boston Scientific

Marlborough, MA, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

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!

  1. Conduct risk assessments for new and existing medical device products, identifying potential hazards and implementing risk mitigation strategies.
  2. Develop and maintain risk management processes and procedures in accordance with global regulations and standards.
  3. Collaborate with cross-functional teams to ensure that risk management is integrated throughout the product development and manufacturing processes.
  4. Monitor and analyze changes in regulatory requirements and communicate any potential impact on product risk management to relevant stakeholders.
  5. Provide guidance and training to team members on risk management principles and practices.
  6. Maintain and update risk management documentation, including risk management plans, hazard analysis, and risk management reports.
  7. Participate in product design reviews to identify potential risks and provide recommendations for risk reduction.
  8. Conduct audits and assessments to ensure compliance with risk management requirements.
  9. Serve as a subject matter expert on risk management, providing support and guidance to other departments as needed.
  10. Continuously evaluate and improve risk management processes to meet business needs and regulatory requirements.
  11. Communicate risk management updates and progress to management and other stakeholders.
  12. Collaborate with external partners, such as regulatory agencies and notified bodies, on risk management-related issues.
  13. Stay informed about industry trends and developments related to risk management and incorporate them into the company's practices.
  14. Mentor and train junior risk management team members to develop their skills and expertise.
Where is this job?
This job is located at Marlborough, MA, USA
Job Qualifications
  • 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.

Required Skills
  • Product Development

  • Quality Assurance

  • Change Management

  • Process Improvement

  • Project Management

  • Data Analysis

  • Communication

  • Compliance Management

  • Risk assessment

  • Risk Mitigation

  • Cross-Functional Collaboration

  • Regulatory Affairs

Soft Skills
  • Communication

  • Conflict Resolution

  • Leadership

  • Time management

  • creativity

  • Organization

  • Teamwork

  • Adaptability

  • Problem-Solving

  • Empathy

Compensation

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.

Additional Information
Boston Scientific is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedJanuary 16th, 2024
Apply BeforeApril 11th, 2026
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About Boston Scientific

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.

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