Abbott
Regulatory Operations Compliance Project Manager - Medical Devices (on-site)
Abbott, Saint Paul, Minnesota, United States
Regulatory Operations Compliance Project Manager - Medical Devices (on-site)
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 114,000 colleagues serve people in more than 160 countries. The Opportunity We are looking for a
Regulatory Operations Compliance Project Manager
to join our team on-site out of our Maple Grove, or St. Paul, MN locations. This Compliance Manager, Global Regulatory Operations would be structured under Global Regulatory Services managing projects related to harmonized regulatory processes in Abbott’s Medical Device Division. As an individual contributor, the function of a Compliance Manager is to combine the knowledge of Regulatory, Quality and Compliance to manage implementation of global emerging regulations and improve procedural compliance in response to Abbott Regulatory teams’ requests working closely with the international regulatory affiliates, the medical device business unit RA teams and cross functional groups. The compliance projects require an experienced Regulatory mindset to lead complex cross functional/cross business strategic discussions and projects. What You’ll Work On Lead Regulatory process/procedure updates Implement emerging regulation requirements into Regulatory documentation with alignment with Abbott cross BU/ cross functional teams Develop and/or author new regulatory policies, processes and SOPs Facilitate procedure implementation Provide strategic input and technical guidance on regulatory requirements for process decisions Evaluate regulatory risks of division policies, processes, procedures Develop and mentor regulatory professionals Drive change order activities Create supplemental training materials Review and follow document quality system structure Lead team meetings and document meeting minutes Work on process workflow development teams collaborating with Abbott IT system enhancement teams Author communications and presentations for upper management Required Qualifications 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Bachelor's Degree in a related field OR an equivalent combination of education and work experience Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals). Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences. Domestic and international regulatory guidelines, policies and regulations. Lead functional groups in the development of relevant data to complete a regulatory submission. Preferred Qualifications Familiarity with Regulatory Affairs departmental responsibilities and processes Familiarity of medical device regulatory requirements and submission/registration activities Proven success managing multiple projects and priorities Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields. Master’s or Ph.D. in a technical area Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) 5+ years’ experience in a regulated industry CAPA experience Windchill experience Procedural Writing Regulatory Change Assessment International Product Registration support Ad and Promotional Material - Regulatory Review Project management skills – organize and host meetings Quality System maintenance activities Documenting Justification for change from Regulatory perspective Regulatory history, guidelines, policies, standards, practices, requirements and precedents GDP Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at
www.abbott.com , on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews. The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted. Seniority level
Mid-Senior level Employment type
Full-time Job function
Finance and Sales Industries
Hospitals and Health Care Abbott is an Equal Opportunity Employer. Referrals increase your chances of interviewing at Abbott.
#J-18808-Ljbffr
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 114,000 colleagues serve people in more than 160 countries. The Opportunity We are looking for a
Regulatory Operations Compliance Project Manager
to join our team on-site out of our Maple Grove, or St. Paul, MN locations. This Compliance Manager, Global Regulatory Operations would be structured under Global Regulatory Services managing projects related to harmonized regulatory processes in Abbott’s Medical Device Division. As an individual contributor, the function of a Compliance Manager is to combine the knowledge of Regulatory, Quality and Compliance to manage implementation of global emerging regulations and improve procedural compliance in response to Abbott Regulatory teams’ requests working closely with the international regulatory affiliates, the medical device business unit RA teams and cross functional groups. The compliance projects require an experienced Regulatory mindset to lead complex cross functional/cross business strategic discussions and projects. What You’ll Work On Lead Regulatory process/procedure updates Implement emerging regulation requirements into Regulatory documentation with alignment with Abbott cross BU/ cross functional teams Develop and/or author new regulatory policies, processes and SOPs Facilitate procedure implementation Provide strategic input and technical guidance on regulatory requirements for process decisions Evaluate regulatory risks of division policies, processes, procedures Develop and mentor regulatory professionals Drive change order activities Create supplemental training materials Review and follow document quality system structure Lead team meetings and document meeting minutes Work on process workflow development teams collaborating with Abbott IT system enhancement teams Author communications and presentations for upper management Required Qualifications 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Bachelor's Degree in a related field OR an equivalent combination of education and work experience Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals). Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences. Domestic and international regulatory guidelines, policies and regulations. Lead functional groups in the development of relevant data to complete a regulatory submission. Preferred Qualifications Familiarity with Regulatory Affairs departmental responsibilities and processes Familiarity of medical device regulatory requirements and submission/registration activities Proven success managing multiple projects and priorities Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields. Master’s or Ph.D. in a technical area Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) 5+ years’ experience in a regulated industry CAPA experience Windchill experience Procedural Writing Regulatory Change Assessment International Product Registration support Ad and Promotional Material - Regulatory Review Project management skills – organize and host meetings Quality System maintenance activities Documenting Justification for change from Regulatory perspective Regulatory history, guidelines, policies, standards, practices, requirements and precedents GDP Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at
www.abbott.com , on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews. The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted. Seniority level
Mid-Senior level Employment type
Full-time Job function
Finance and Sales Industries
Hospitals and Health Care Abbott is an Equal Opportunity Employer. Referrals increase your chances of interviewing at Abbott.
#J-18808-Ljbffr