Abbott
Regulatory Affairs Manager - Structural Heart
Abbott, Saint Paul, Minnesota, United States, 55199
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.
JOB DESCRIPTION:
About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott 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: Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the
Freedom 2 Save
student debt program and
FreeU
education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. Structural Heart Business Mission: why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. The Opportunity We are recruiting for a
Regulatory Affairs Manager
to join our team in St. Paul, MN. In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. You will be responsible for managing a small team overseeing the mechanical heart valve and annuloplasty ring product portfolio, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, compiling regulatory submissions, and ensuring data is effectively presented for the registration of products worldwide. What You’ll Work On Managing a team of regulatory specialists Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on regulatory requirements for Class III and Class II medical devices. Assess the acceptability of documentation for Class III and Class II medical device submissions and effectively communicate regulatory guidance. Compile, prepare, review and submit Class III and Class II medical device submissions to regulatory agencies. Interact, answer questions and negotiate with regulatory agencies during the submission review process to obtain submission approval. Evaluate proposed design and manufacturing changes for regulatory impact and implement any required regulatory action. Utilize technical regulatory skills to propose strategies on complex issues. Monitor regulatory landscape for impact to company products and help to develop solutions to regulatory obstacles, with other members of regulatory and related teams. Ensure compliance with product post marketing approval requirements. Review product labeling and promotional material to ensure compliance with relevant regulatory requirements. Help to develop regulatory strategy for Class III and Class II medical devices, with other regulatory team members. Provide regulatory support for internal and external audits. Required Qualifications Bachelor’s Degree or an equivalent combination of education and work experience 8+ years’ experience in the medical device industry, with 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices. Ability to work effectively on project teams and be able to juggle multiple and competing priorities. Scientific writing experience. Strong verbal, written and presentation skills with the ability to effectively communicate at multiple levels in the organization. Preferred Qualifications Bachelor’s Degree in Engineering, Medical, Science or related discipline. Advanced degree Experience with EU, Canada, Japan, China, Australia and other international medical device regulations and submissions Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization. Supervisory experience Previous experience with Class III EU MDR and PMA submissions Proficient with MS Office (Word, Excel, Outlook). Apply Now * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. 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. Connect with us at
www.abbott.com
, on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $95,000.00 – $190,000.00
In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Regulatory Operations
DIVISION:
SH Structural Heart
LOCATION:
United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % 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 link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf #J-18808-Ljbffr
About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott 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: Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the
Freedom 2 Save
student debt program and
FreeU
education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. Structural Heart Business Mission: why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. The Opportunity We are recruiting for a
Regulatory Affairs Manager
to join our team in St. Paul, MN. In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. You will be responsible for managing a small team overseeing the mechanical heart valve and annuloplasty ring product portfolio, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, compiling regulatory submissions, and ensuring data is effectively presented for the registration of products worldwide. What You’ll Work On Managing a team of regulatory specialists Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on regulatory requirements for Class III and Class II medical devices. Assess the acceptability of documentation for Class III and Class II medical device submissions and effectively communicate regulatory guidance. Compile, prepare, review and submit Class III and Class II medical device submissions to regulatory agencies. Interact, answer questions and negotiate with regulatory agencies during the submission review process to obtain submission approval. Evaluate proposed design and manufacturing changes for regulatory impact and implement any required regulatory action. Utilize technical regulatory skills to propose strategies on complex issues. Monitor regulatory landscape for impact to company products and help to develop solutions to regulatory obstacles, with other members of regulatory and related teams. Ensure compliance with product post marketing approval requirements. Review product labeling and promotional material to ensure compliance with relevant regulatory requirements. Help to develop regulatory strategy for Class III and Class II medical devices, with other regulatory team members. Provide regulatory support for internal and external audits. Required Qualifications Bachelor’s Degree or an equivalent combination of education and work experience 8+ years’ experience in the medical device industry, with 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices. Ability to work effectively on project teams and be able to juggle multiple and competing priorities. Scientific writing experience. Strong verbal, written and presentation skills with the ability to effectively communicate at multiple levels in the organization. Preferred Qualifications Bachelor’s Degree in Engineering, Medical, Science or related discipline. Advanced degree Experience with EU, Canada, Japan, China, Australia and other international medical device regulations and submissions Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization. Supervisory experience Previous experience with Class III EU MDR and PMA submissions Proficient with MS Office (Word, Excel, Outlook). Apply Now * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. 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. Connect with us at
www.abbott.com
, on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $95,000.00 – $190,000.00
In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Regulatory Operations
DIVISION:
SH Structural Heart
LOCATION:
United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % 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 link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf #J-18808-Ljbffr