Job Details

Overview

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.

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 Rhythm 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 Rhythm 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

• Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. MS in a technical area or MBA is preferred. PhD in a technical area or law is helpful. Certification is a plus (e.g., RAC).
• Minimum 4 years experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of regulatory experience preferred; related areas may be considered. Higher education may compensate for years of experience.

Background / Skills / Knowledge

• 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
• Domestic and international regulatory guidelines, policies and regulations
• Ethical guidelines of the regulatory profession, clinical research and regulatory process

Communication Skills

• 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
• Negotiate internally and externally with regulatory agencies
• Plan and conduct meetings

Cognitive Skills

• 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
• Have broad knowledge of various technical alternatives and their impact on the business
• Exercise good and ethical judgment within policy and regulations
• Use knowledge of business functions and cross-group dependencies
• Define regulatory strategy
• Follow scientific arguments, identify data needs and solve regulatory issues
• Perform risk assessment or analysis
• Lead functional groups in developing data for regulatory submissions

Preferred Qualifications

• Experience with LATAM regulatory parties
• Fluent in Spanish 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
• 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 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 data development for regulatory submissions

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.

About the company

Abbott

Be vigilant about potential scams, phishing attempts, or fraudulent activities, and seek credible sources or reviews to assess the trustworthiness of the company. Remember, your personal and financial security is paramount. SupportFinity is not responsible for any consequences that may arise from disclosing such information to unauthorized or fraudulent entities.