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.
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.
- 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.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.
