Abbott Laboratories
Regulatory Affairs Project Manager
Abbott Laboratories, Alameda, California, United States, 94501
JOB DESCRIPTION:
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. Our business purpose is to restore health and improve quality of life through the design and provision of device and Cardiac Rythm Management solutions
We are seeking a Regulatory Affairs Project Manager to join our Lingo team in Alameda CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include:
Utilize technical regulatory skills to propose strategies on complex issues
Determine submission and approval requirements
Required Qualifications –
Bachelors Degree (± 16 years) , Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 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. Note: Higher education may compensate for years of experience.
**Background / Skills / Knowledge Regulatory Knowledge of (as applicable):**
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Principles and requirements of applicable product laws
Submission/registration types and requirements
Principles and requirements of promotion, advertising and labeling
International treaties and regional, national, local and territorial trade requirements, agreements and considerations
**Communication Skills or Ability to:**
Work with cross-functional teams
Work with people from various disciplines and cultures
**Cognitive Skills or Ability to:**
Think analytically with good problem solving skills
Has broad knowledge of various technical alternatives and their potential impact on the business
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Preferred Qualifications –
Experience with LATAM regulatory partiesPrevious experience with Class III IDE submissions and/or PMA submissions or EU Technical Files or Canada Class III & IV License Applications Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization 8+ years of experience related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class II, and III medical devices or EU Technical Files or Canada Class III & IV License Applications
Ability to work effectively on project teams and lead functional groups in the development of relevant data to complete a regulatory submission. #J-18808-Ljbffr
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. Our business purpose is to restore health and improve quality of life through the design and provision of device and Cardiac Rythm Management solutions
We are seeking a Regulatory Affairs Project Manager to join our Lingo team in Alameda CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include:
Utilize technical regulatory skills to propose strategies on complex issues
Determine submission and approval requirements
Required Qualifications –
Bachelors Degree (± 16 years) , Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 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. Note: Higher education may compensate for years of experience.
**Background / Skills / Knowledge Regulatory Knowledge of (as applicable):**
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Principles and requirements of applicable product laws
Submission/registration types and requirements
Principles and requirements of promotion, advertising and labeling
International treaties and regional, national, local and territorial trade requirements, agreements and considerations
**Communication Skills or Ability to:**
Work with cross-functional teams
Work with people from various disciplines and cultures
**Cognitive Skills or Ability to:**
Think analytically with good problem solving skills
Has broad knowledge of various technical alternatives and their potential impact on the business
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Preferred Qualifications –
Experience with LATAM regulatory partiesPrevious experience with Class III IDE submissions and/or PMA submissions or EU Technical Files or Canada Class III & IV License Applications Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization 8+ years of experience related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class II, and III medical devices or EU Technical Files or Canada Class III & IV License Applications
Ability to work effectively on project teams and lead functional groups in the development of relevant data to complete a regulatory submission. #J-18808-Ljbffr