Regulatory Affairs Specialist I
- Employer
- Abbott
- Location
- Minneapolis
- Salary
- Competitive
View more
- Industry
- Government and Public Services
- Role
- Other
- Job Type
- Long-Term
- Hours
- Full Time
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
About Abbott:
Leading an active lifestyle is important to the many people we serve. In Abbott's Electrophysiology division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology, allowing people to restore their health and get on with their lives.
Our location in Plymouth, MN., currently has an opportunity for Regulatory Affairs Specialist, supporting our Electro-Physiology team. You will have the opportunity to support the process that allows life-saving devices to be used by patients all across the globe!
**What You'll Do:**
+ Manage international regulatory submissions to ensure timely regulatory approval of medical devices, with a primary focus on Abbott Electrophysiology (EP) product lines.
+ Ensure Abbott products and procedures comply with applicable regulatory agency requirements and guidelines.
+ Monitor changing regulations in international geographies and translate/communicate these requirements to Abbott product development and continuous improvement project teams.
+ Work with cross-functional teams to prepare and execute regulatory strategy, change management and product release activities.
+ Manage multiple concurrent projects and deadlines
+ Performs other related duties and responsibilities, on occasion, as assigned
+ Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
**Education and Experience You'll Bring:**
+ Bachelor's degree with a minimum of 1 to 4 years experience working in the medical device or similar regulated industry preferred
+ Ability to schedule and organize multiple projects
+ Ability to communicate effectively with internal and external customers and team members.
+ Requires ability to be innovative, resourceful, and work with minimal direction
+ Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams
+ Ability to work in a highly matrixed and geographically diverse business environment.
+ Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
+ Ability to leverage and/or engage others to accomplish projects.
+ Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
+ Ability to travel up to 20%, including international travel
**WHAT WE OFFER**
At Abbott, you can have a good job that can grow into a great career. We offer:
+ **Training and career development** , with onboarding programs for new employees and tuition assistance
+ **Financial security** through competitive compensation, incentives and retirement plans
+ **Health care and well-being programs** including medical, dental, vision, wellness and occupational health programs
+ **Paid time off**
+ **401(k)** retirement savings with a generous company match
+ **The stability of a company** with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully:
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
About Abbott:
Leading an active lifestyle is important to the many people we serve. In Abbott's Electrophysiology division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology, allowing people to restore their health and get on with their lives.
Our location in Plymouth, MN., currently has an opportunity for Regulatory Affairs Specialist, supporting our Electro-Physiology team. You will have the opportunity to support the process that allows life-saving devices to be used by patients all across the globe!
**What You'll Do:**
+ Manage international regulatory submissions to ensure timely regulatory approval of medical devices, with a primary focus on Abbott Electrophysiology (EP) product lines.
+ Ensure Abbott products and procedures comply with applicable regulatory agency requirements and guidelines.
+ Monitor changing regulations in international geographies and translate/communicate these requirements to Abbott product development and continuous improvement project teams.
+ Work with cross-functional teams to prepare and execute regulatory strategy, change management and product release activities.
+ Manage multiple concurrent projects and deadlines
+ Performs other related duties and responsibilities, on occasion, as assigned
+ Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
**Education and Experience You'll Bring:**
+ Bachelor's degree with a minimum of 1 to 4 years experience working in the medical device or similar regulated industry preferred
+ Ability to schedule and organize multiple projects
+ Ability to communicate effectively with internal and external customers and team members.
+ Requires ability to be innovative, resourceful, and work with minimal direction
+ Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams
+ Ability to work in a highly matrixed and geographically diverse business environment.
+ Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
+ Ability to leverage and/or engage others to accomplish projects.
+ Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
+ Ability to travel up to 20%, including international travel
**WHAT WE OFFER**
At Abbott, you can have a good job that can grow into a great career. We offer:
+ **Training and career development** , with onboarding programs for new employees and tuition assistance
+ **Financial security** through competitive compensation, incentives and retirement plans
+ **Health care and well-being programs** including medical, dental, vision, wellness and occupational health programs
+ **Paid time off**
+ **401(k)** retirement savings with a generous company match
+ **The stability of a company** with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully:
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
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