Post by claire on Sept 14, 2015 14:11:26 GMT
Regulatory Affairs Junior Manager Job
Location: Maplewood, Mn, US
Job ID: M2ARDM1516
Description: A Global Innovation Company
3M is a global innovation company that never stops inventing. Over the years, our innovations have
improved daily life for hundreds of millions of people all over the world. We have made driving at
night easier, made buildings safer, and made consumer electronics lighter, less energy-intensive and
less harmful to the environment. We even helped put a man on the moon. Every day at 3M, one idea
always leads to the next, igniting momentum to make progress possible around the world.
3M is seeking a Regulatory Affairs Junior Manager for the 3M ESPE Dental Products Division located
in Maplewood, MN. Be part of what’s next!
Job Summary:
The person hired for the position of Regulatory Affairs Junior Manager will primarily be responsible
for global product registration activities, and regulatory compliance, for the 3M ESPE Digital business
portfolio.
For additional information please visit: www.M2ARDM.com/3M_US/Dental/
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
- 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 a (1) year Regulatory Affairs and/or Quality experience
- An experience in the Medical Equipment and/or Software industry(ies) would be appreciated
Preferred Qualifications:
- Bachelor’s degree or higher in Biomedical Engineering, Biological Engineering, Chemical Engineering
or related disc from an accredited university
- Knowledge of marking processes and standards (Regulatory Compliance Mark....)
- Knowledge of FDA regulations and proficient in medical devices submissions
- Knowledge of European regulations and proficient in medical devices submissions
- Familiarity with global medical devices regulations
- Regulatory or quality experience with medical devices
- Knowledge of medical equipment
- Ability to lead global cross-functional project Team
- Excellent technical communication skills (oral, written and presentation) with the corresponding
ability to influence at all levels
Travel: May include up to 10% domestic/international
Relocation: Is 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!
3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment
on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability,
or veteran status.
Contact us
If you are interested in this role please email your CV to M2ipil.english@gmail.com
Location: Maplewood, Mn, US
Job ID: M2ARDM1516
Description: A Global Innovation Company
3M is a global innovation company that never stops inventing. Over the years, our innovations have
improved daily life for hundreds of millions of people all over the world. We have made driving at
night easier, made buildings safer, and made consumer electronics lighter, less energy-intensive and
less harmful to the environment. We even helped put a man on the moon. Every day at 3M, one idea
always leads to the next, igniting momentum to make progress possible around the world.
3M is seeking a Regulatory Affairs Junior Manager for the 3M ESPE Dental Products Division located
in Maplewood, MN. Be part of what’s next!
Job Summary:
The person hired for the position of Regulatory Affairs Junior Manager will primarily be responsible
for global product registration activities, and regulatory compliance, for the 3M ESPE Digital business
portfolio.
For additional information please visit: www.M2ARDM.com/3M_US/Dental/
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
- 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 a (1) year Regulatory Affairs and/or Quality experience
- An experience in the Medical Equipment and/or Software industry(ies) would be appreciated
Preferred Qualifications:
- Bachelor’s degree or higher in Biomedical Engineering, Biological Engineering, Chemical Engineering
or related disc from an accredited university
- Knowledge of marking processes and standards (Regulatory Compliance Mark....)
- Knowledge of FDA regulations and proficient in medical devices submissions
- Knowledge of European regulations and proficient in medical devices submissions
- Familiarity with global medical devices regulations
- Regulatory or quality experience with medical devices
- Knowledge of medical equipment
- Ability to lead global cross-functional project Team
- Excellent technical communication skills (oral, written and presentation) with the corresponding
ability to influence at all levels
Travel: May include up to 10% domestic/international
Relocation: Is 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!
3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment
on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability,
or veteran status.
Contact us
If you are interested in this role please email your CV to M2ipil.english@gmail.com