
Senior Regulatory Affairs Associate
Are you a self-motivated and detail-oriented individual with a passion for regulatory affairs? Look no further than 3M's Senior Regulatory Affairs Associate position! We are seeking a highly skilled professional to join our team and ensure compliance with regulations and standards for our products. In this role, you will play a critical role in bringing innovative solutions to market while maintaining the highest level of quality and safety. If you have a strong background in regulatory affairs and possess excellent communication and project management skills, we want to hear from you!
- Ensure compliance with all applicable regulations and standards for 3M products.
- Stay up-to-date with regulatory changes and communicate any potential impact to the company.
- Conduct thorough reviews and assessments of product labeling, packaging, and promotional materials to ensure accuracy and compliance.
- Collaborate with cross-functional teams to develop and implement strategies for product approvals and registrations.
- Communicate with regulatory agencies and respond to any inquiries or requests for information.
- Prepare and submit regulatory submissions, including 510(k) applications, IDEs, and PMAs, in a timely and efficient manner.
- Conduct internal audits to ensure compliance with regulatory requirements and identify any areas for improvement.
- Keep accurate and organized records of all regulatory activities and submissions.
- Serve as a subject matter expert on regulatory affairs and provide guidance and support to other team members.
- Continuously monitor and assess the competitive landscape and potential regulatory risks.
- Participate in company-wide initiatives to improve processes and ensure regulatory compliance.
- Represent the company in meetings with regulatory agencies and participate in industry conferences and events.
- Mentor and train junior regulatory affairs associates as needed.
Bachelor's Degree In A Relevant Field Such As Biology, Chemistry, Or Pharmaceutical Sciences.
Minimum Of 5 Years Experience In Regulatory Affairs Within The Medical Device Or Pharmaceutical Industry.
Knowledge Of Fda Regulations, Guidelines, And Submission Requirements.
Strong Communication And Project Management Skills.
Experience Interacting With Regulatory Agencies And Managing Product Registrations And Approvals.
Quality Assurance
Project Management
Technical Writing
Risk assessment
Regulatory compliance
Product Lifecycle Management
FDA regulations
Product Registration
Regulatory Strategy
Labeling Requirements
Global Submissions
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
collaboration
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Regulatory Affairs Associate in Maplewood, MN, USA is $65,000 to $100,000 per year. This range can vary depending on the specific company, level of experience, and additional skills and qualifications of the individual.
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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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