Beckman Coulter

Senior Analyst Quality Assurance & Regulatory Affairs

Beckman Coulter

Marseille, France
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Are you a highly skilled and experienced professional in the field of Quality Assurance and Regulatory Affairs? Are you looking for a challenging and rewarding career opportunity with a global leader in the healthcare industry? If so, then we have a perfect role for you at Beckman Coulter!We are currently seeking a Senior Analyst to join our Quality Assurance and Regulatory Affairs team. In this role, you will play a crucial role in ensuring the quality and compliance of our products, while also maintaining regulatory compliance with various governing bodies. As a Senior Analyst, you will have the opportunity to utilize your expertise and knowledge to make a significant impact on the success of our company and the well-being of our customers.To excel in this role, you must possess a thorough understanding of quality management systems, regulatory requirements, and industry standards. You must also have strong analytical skills, attention to detail, and the ability to work independently. If you are passionate about quality and compliance and have a drive to constantly improve processes, then we want to hear from you! Join us at Beckman Coulter and be a part of a dynamic team that is dedicated to improving the world of healthcare.

  • Develop and maintain quality management systems to ensure compliance with industry standards and regulatory requirements.
  • Conduct audits and inspections to identify and address potential areas of non-compliance.
  • Analyze data and information to identify trends and areas for improvement in quality and regulatory compliance.
  • Collaborate with cross-functional teams to develop and implement corrective and preventive actions.
  • Review and approve documentation for product development, manufacturing, and distribution to ensure compliance with regulations.
  • Monitor changes in regulations and communicate potential impacts to the company.
  • Train and educate employees on quality and regulatory requirements to maintain a culture of compliance.
  • Manage and maintain relationships with regulatory agencies and other governing bodies.
  • Participate in the development and implementation of new products and processes to ensure compliance with regulations.
  • Lead investigations into quality issues and provide recommendations for corrective actions.
  • Conduct risk assessments and establish risk management strategies to mitigate potential quality and regulatory risks.
  • Act as a subject matter expert in quality and regulatory affairs and provide guidance and support to other team members.
  • Continuously assess and improve the quality management system to meet changing industry standards and regulatory requirements.
  • Represent the company during regulatory inspections and audits.
  • Communicate and collaborate with stakeholders to ensure quality and regulatory compliance goals are met.
  • Maintain accurate and up-to-date records related to quality and regulatory activities.
Where is this job?
This job is located at Marseille, France
Job Qualifications
  • Bachelor's Degree In A Science Or Engineering Field, Or Equivalent Experience In Quality Assurance And Regulatory Affairs.

  • Minimum Of 5 Years Of Experience In A Quality Assurance Or Regulatory Affairs Role In The Medical Device Industry.

  • Knowledge Of Fda Regulations And International Quality Standards, Such As Iso 13485.

  • Experience With Quality Management Systems, Including Document Control, Corrective And Preventive Actions, And Internal Audits.

  • Strong Analytical And Problem-Solving Skills, With The Ability To Interpret And Apply Complex Regulations And Standards To Ensure Compliance.

Required Skills
  • Risk Management

  • Quality Assurance

  • Process Improvement

  • Data Analysis

  • Problem Solving

  • Auditing

  • Quality Control

  • Team Leadership

  • Regulatory compliance

  • Documentation management

  • Compliance monitoring

  • Project

Soft Skills
  • Conflict Resolution

  • Customer Service

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Communication Skills

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Senior Analyst Quality Assurance & Regulatory Affairs in Marseille, France is €50,000-€80,000 per year. However, this can vary depending on the company, industry, and level of experience of the individual. Some companies may offer higher salaries for this position, while others may offer lower salaries. Additionally, factors such as qualifications, job responsibilities, and location can also impact the salary for this role.

Additional Information
Beckman Coulter 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 LanguagesFrench
Job PostedJanuary 10th, 2025
Apply BeforeApril 11th, 2026
This job posting is from a verified source. 
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About Beckman Coulter

Beckman Coulter Inc., is a Danaher Corporation company that develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing.

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