3M

Regulatory Affairs International Project Manager

3M

Maplewood, MN, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to 3M, a global leader in innovative technology and cutting-edge solutions. We are currently seeking a highly skilled and experienced Regulatory Affairs International Project Manager to join our dynamic team. In this role, you will have the opportunity to work on exciting projects and initiatives that will shape the future of our company. As a key member of our Regulatory Affairs team, you will be responsible for managing international regulatory submissions and ensuring compliance with global regulations. We are looking for a driven and detail-oriented individual with a strong background in regulatory affairs and project management. If you are ready to take on a challenging and rewarding role with a company that values innovation and excellence, we encourage you to apply.

  1. Manage international regulatory submissions: The primary responsibility of the Regulatory Affairs International Project Manager will be to oversee and manage all international regulatory submissions for the company. This will involve understanding and navigating the various regulatory requirements and processes in different countries and ensuring timely and accurate submissions.
  2. Ensure compliance with global regulations: The Regulatory Affairs International Project Manager will be responsible for staying up-to-date with global regulatory requirements and ensuring that all submissions and processes are in compliance with these regulations. This may involve conducting regular audits and reviews to identify and address any potential compliance issues.
  3. Collaborate with cross-functional teams: The role will require close collaboration with cross-functional teams such as research and development, marketing, and legal to ensure that all projects and initiatives are aligned with regulatory requirements and timelines.
  4. Develop and implement regulatory strategies: The Regulatory Affairs International Project Manager will play a key role in developing and implementing regulatory strategies for new products and initiatives. This may involve conducting regulatory assessments, identifying potential risks, and providing recommendations to ensure successful market entry.
  5. Manage project timelines and budgets: The role will involve overseeing project timelines and budgets for international regulatory submissions and initiatives. The Regulatory Affairs International Project Manager will need to be detail-oriented and have strong project management skills to ensure that projects are completed on time and within budget.
  6. Stay informed on industry trends and regulations: The Regulatory Affairs International Project Manager will be responsible for staying informed on the latest industry trends and regulatory changes that may impact the company. This will involve attending conferences, workshops, and training sessions to stay up-to-date on best practices and changes in regulations.
  7. Ensure high-quality submissions and documentation: As the company's representative to regulatory agencies, the Regulatory Affairs International Project Manager will be responsible for ensuring that all submissions and documentation meet high-quality standards and are in line with regulatory requirements.
  8. Train and mentor team members: The role may involve training and mentoring other team members on regulatory processes and requirements. The Regulatory Affairs International Project Manager will need to have
Where is this job?
This job is located at Maplewood, MN, USA
Job Qualifications
  • Knowledge Of Global Regulatory Requirements: A Strong Understanding Of International Regulations And Standards Related To The Medical Device Industry Is Essential For An International Project Manager At 3M. This Includes Knowledge Of Fda Regulations, Ce Marking Requirements, And Other Global Regulatory Bodies.

  • Project Management Skills: The Ability To Effectively Manage Complex Projects Across Multiple Countries And Cultures Is Crucial For Success In This Role. A Regulatory Affairs International Project Manager At 3M Must Have Excellent Organizational, Communication, And Problem-Solving Skills To Ensure The Timely And Successful Completion Of Projects.

  • Multilingual Abilities: Fluency In Multiple Languages, Particularly Those Commonly Used In The Medical Device Industry, Is Highly Desirable For This Position. The Ability To Communicate Effectively With International Stakeholders In Their Native Language Can Help To Facilitate Regulatory Approvals And Project Management.

  • Experience With Product Registrations: Previous Experience With International Product Registrations Is A Must-Have Qualification For This Role. Familiarity With The Submission Process, Documentation Requirements, And Timelines For Different Countries Can Help To Ensure The Timely Approval Of 3M's Medical Devices In Various Markets.

  • Understanding Of Quality Management Systems: Regulatory Affairs International Project Managers Must Have A Strong Understanding Of Quality Management Systems (Qms) And How They Relate To Regulatory Compliance. This Includes Knowledge Of Iso Standards And Their Application In Different Countries, As Well As Experience With Auditing And Quality Assurance Processes.

Required Skills
  • Quality Assurance

  • Project Management

  • Risk assessment

  • Regulatory compliance

  • Cross-Functional Collaboration

  • Product Registration

  • Regulatory Submissions

  • Regulatory Strategy

  • International Regulations

  • Labeling Requirements

  • Global Standards

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 Regulatory Affairs International Project Manager in Maplewood, MN, USA is between $100,000 and $130,000 per year. This may vary depending on the specific company, experience level, and other factors such as education and certifications.

Additional Information
3M 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 PostedDecember 22nd, 2023
Apply BeforeAugust 19th, 2025
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About 3M

The 3M Company is an American multinational conglomerate corporation operating in the fields of industry, worker safety, US health care, and consumer goods.

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