Regulatory Affairs Project Manager

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:

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, nutritional's and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.  

Job Description:

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.  
• Cardiac Rythm Management 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 Cardiac Rythm Management solutions   

The Opportunity –

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.  

What You’ll Work On -  

Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include:   

Strategic Planning:

•  Develop new regulatory policies, processes and SOPs and train key personnel on them   
•  Evaluate regulatory risks of division policies, processes, procedures   
• Provide regulatory input to product lifecycle planning   
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management   
•  Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes   
• Assist in regulatory due diligence for potential and new acquisitions   
• Utilize technical regulatory skills to propose strategies on complex issues   
• Determine submission and approval requirements   

• Identify Emerging Issues

• Monitor trade association positions for impact on company products   
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams   
• Develop and mentor regulatory professionals   

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   
• Regulatory agency structure, processes and key personnel   
•  Principles and requirements of applicable product laws   
• Submission/registration types and requirements   
• GxPs (GCPs, GLPs, GMPs)   
• Principles and requirements of promotion, advertising and labeling   
• International treaties and regional, national, local and territorial trade requirements, agreements and considerations   
•  Domestic and international regulatory guidelines, policies and regulations   
• Ethical guidelines of the regulatory profession, clinical research and regulatory process   

Communication Skills Or Ability To:

• Communicate effectively verbally and in writing   
• Communicate with diverse audiences and personnel   
•  Write and edit technical documents   
• Work with cross-functional teams   
• Work with people from various disciplines and cultures   
• Write and edit technical documents   
• Negotiate internally and externally with regulatory agencies   
• Plan and conduct meetings   

Cognitive Skills Or Ability To:

•  Pay strong attention to detail   

• Manage Projects

• Create project plans and timelines   
• Juggle multiple and competing priorities   
• Think analytically with good problem solving skills   
• Organize and track complex information   
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results   
• Has broad knowledge of various technical alternatives and their potential impact on the business   
• Exercise good and ethical judgment within policy and regulations   
• Use in-depth knowledge of business functions and cross group dependencies/ relationships   

• Define Regulatory Strategy

• Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues   
•  Perform risk assessment or analysis   
•  Lead functional groups in the development of relevant data to complete a regulatory submission  

Preferred Qualifications –

• Experience with LATAM regulatory parties 
• Fluent in Spanish is preferred 
•  Bachelor’s degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields. 
• Advanced degree in Engineering, Sciences, or related discipline 
• Previous 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. 

The base pay for this position is

$112,000.00 – $224,000.00

In specific locations, the pay range may vary from the range posted.

Job Family:

Regulatory Operations

Division:

LNGO Lingo

Location:

United States > Alameda : 2901 Harbor Bay Parkway

Additional Locations:

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 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