Abbott
Regulatory Operations Compliance Project Manager - Medical Devices (on-site)
Abbott, Saint Paul, Minnesota, United States, 55199
Overview
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals and branded generic medicines. Abbott has 114,000 colleagues serving people in more than 160 countries. JOB DESCRIPTION:
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to a range of benefits and opportunities. The Opportunity
We are looking for our next
Regulatory Operations Compliance Project Manager
to join our team on-site out of our Maple Grove, or St. Paul, MN locations. This Compliance Project Manager, Global Regulatory Operations would be structured under Global Regulatory Services managing projects related to harmonized regulatory activities in Abbott’s medical device division. As an individual contributor, the function of a Compliance Manager is to combine knowledge of Regulatory, Quality and Compliance to manage implementation projects for emerging regulations and lead/drive quality compliance metrics for the Regulatory shared service organization. What You’ll Work On
Lead procedural updates and emerging regulation implementation working with cross BU/ cross functional teams Develop 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
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). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 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
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 Familiarity with Regulatory Affairs departmental responsibilities and processes Proven success managing multiple projects and priorities 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,requirementsand 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. Compensation
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. JOB FAMILY:
Regulatory Operations DIVISION:
MD Medical Devices LOCATION:
United States > Maple Grove: 6820 Wedgwood Road N. United States > Minnesota > St. Paul > Lillehei: One Lillehei Plaza WORK SHIFT:
Standard TRAVEL:
Yes, 5 % of the Time MEDICAL SURVEILLANCE:
No SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists); Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals and branded generic medicines. Abbott has 114,000 colleagues serving people in more than 160 countries. JOB DESCRIPTION:
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to a range of benefits and opportunities. The Opportunity
We are looking for our next
Regulatory Operations Compliance Project Manager
to join our team on-site out of our Maple Grove, or St. Paul, MN locations. This Compliance Project Manager, Global Regulatory Operations would be structured under Global Regulatory Services managing projects related to harmonized regulatory activities in Abbott’s medical device division. As an individual contributor, the function of a Compliance Manager is to combine knowledge of Regulatory, Quality and Compliance to manage implementation projects for emerging regulations and lead/drive quality compliance metrics for the Regulatory shared service organization. What You’ll Work On
Lead procedural updates and emerging regulation implementation working with cross BU/ cross functional teams Develop 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
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). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 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
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 Familiarity with Regulatory Affairs departmental responsibilities and processes Proven success managing multiple projects and priorities 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,requirementsand 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. Compensation
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. JOB FAMILY:
Regulatory Operations DIVISION:
MD Medical Devices LOCATION:
United States > Maple Grove: 6820 Wedgwood Road N. United States > Minnesota > St. Paul > Lillehei: One Lillehei Plaza WORK SHIFT:
Standard TRAVEL:
Yes, 5 % of the Time MEDICAL SURVEILLANCE:
No SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists); Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
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