Job ID: 75606
3M is seeking a Regulatory Affairs Associate for the 3M ESPE Dental Products Division located in St Paul, MN. Be part of what’s next!
Job Summary:
The person hired for the position of Regulatory Affairs Associate will primarily be responsible for global product registration activities, and regulatory compliance, for the 3M ESPE Digital business portfolio.
Primary Responsibilities include but are not limited to the following:
- Provide regulatory leadership and guidance for new product development and change management activities
- Compile global product registration documents (dossiers, technical files, 510(k)s, etc.) and support global registrations activities
- Develop product registration strategies based on knowledge of Food and Drug Administration (FDA )regulations, European Union (EU) Directive, International Organization for Standardization (ISO) Standards, etc.
- Develop and execute global registration plans and timelines
- Review and assess product design, labeling, manufacturing, etc., based on global requirements
- Assure regulatory compliance for all products and related activities
Basic Qualifications:
- Bachelor’s degree or higher in a Science or Engineering discipline from an accredited university
- Minimum of two (2) years Regulatory Affairs and/or Quality experience
- Minimum of two (2) years experience in the Medical Equipment and/or Software industry(ies)
Preferred Qualifications:
- Bachelor’s degree or higher in Electrical Engineering, Software Engineering, Computer Engineering, Mechanical Engineering, Chemical Engineering or related disc from an accredited University
- Knowledge of electrical marking processes and standards (Underwriters Laboratories-UL, Edison Testing Laboratories-ETL, RCM Mark – Regulatory Compliance Mark etc.)
- Knowledge of FDA regulations and proficient in electronic submissions
- Familiarity with global medical device regulations
- Regulatory Affairs Professional Society—Regulatory Affairs Certification (RAC)
- Regulatory or quality experience with electrical and wireless devices
- Knowledge of digital equipment and Cloud based storage
- Excellent technical communication skills (oral, written and presentation)
- Able to work effectively and collaboratively in a cross-functional team
Location: Maplewood, MN
Travel: May include up to 10% domestic
Relocation: Is not authorized
About 3M
Do you see the world differently? Are you inspired by how a simple shift can result in big change? Do you share your ideas in the hopes of coming up with something even better by working together? Then join 3M! With 88,000 people around the world in more than 70 countries and $30 billion in sales, 3M is committed to building on our rich heritage by bringing our best to the innovations we create. Be part of improving how people live and work every day. Be part of what’s next at 3M! Follow us @3MCareers and learn more at YouTube.com/3MCareers.
Apply now for this exciting opportunity with 3M. 3M is an EEO/AA employer. Women, minorities, veterans, and individuals with disabilities are encouraged to apply.
Posting Notes: ||Maplewood ||Minnesota ||United States ||N/A ||
3M is seeking a Regulatory Affairs Associate for the 3M ESPE Dental Products Division located in St Paul, MN. Be part of what’s next!
Job Summary:
The person hired for the position of Regulatory Affairs Associate will primarily be responsible for global product registration activities, and regulatory compliance, for the 3M ESPE Digital business portfolio.
Primary Responsibilities include but are not limited to the following:
- Provide regulatory leadership and guidance for new product development and change management activities
- Compile global product registration documents (dossiers, technical files, 510(k)s, etc.) and support global registrations activities
- Develop product registration strategies based on knowledge of Food and Drug Administration (FDA )regulations, European Union (EU) Directive, International Organization for Standardization (ISO) Standards, etc.
- Develop and execute global registration plans and timelines
- Review and assess product design, labeling, manufacturing, etc., based on global requirements
- Assure regulatory compliance for all products and related activities
Basic Qualifications:
- Bachelor’s degree or higher in a Science or Engineering discipline from an accredited university
- Minimum of two (2) years Regulatory Affairs and/or Quality experience
- Minimum of two (2) years experience in the Medical Equipment and/or Software industry(ies)
Preferred Qualifications:
- Bachelor’s degree or higher in Electrical Engineering, Software Engineering, Computer Engineering, Mechanical Engineering, Chemical Engineering or related disc from an accredited University
- Knowledge of electrical marking processes and standards (Underwriters Laboratories-UL, Edison Testing Laboratories-ETL, RCM Mark – Regulatory Compliance Mark etc.)
- Knowledge of FDA regulations and proficient in electronic submissions
- Familiarity with global medical device regulations
- Regulatory Affairs Professional Society—Regulatory Affairs Certification (RAC)
- Regulatory or quality experience with electrical and wireless devices
- Knowledge of digital equipment and Cloud based storage
- Excellent technical communication skills (oral, written and presentation)
- Able to work effectively and collaboratively in a cross-functional team
Location: Maplewood, MN
Travel: May include up to 10% domestic
Relocation: Is not authorized
About 3M
Do you see the world differently? Are you inspired by how a simple shift can result in big change? Do you share your ideas in the hopes of coming up with something even better by working together? Then join 3M! With 88,000 people around the world in more than 70 countries and $30 billion in sales, 3M is committed to building on our rich heritage by bringing our best to the innovations we create. Be part of improving how people live and work every day. Be part of what’s next at 3M! Follow us @3MCareers and learn more at YouTube.com/3MCareers.
Apply now for this exciting opportunity with 3M. 3M is an EEO/AA employer. Women, minorities, veterans, and individuals with disabilities are encouraged to apply.
Posting Notes: ||Maplewood ||Minnesota ||United States ||N/A ||