Abbott Regulatory Affairs Project Manager in Santa Clara, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
This is an exciting new Regulatory Affairs Project Manager opening where you will be responsible for managing a new project for Abbott's Vascular division in Santa Clara. The main focus will be international and US regulatory submissions (class III) and you will manage multiple submissions at once. This is a high visibility project where you will work on a brand new combination product and you will also drive collaboration between Abbott and a partner company.
· 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
· Recruit, develop and mentor regulatory professionals
· Assess the acceptability of quality, preclinical and clinical documentation for submission filing
· Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
· Compile, prepare, review and submit regulatory submission to authorities
· Monitor impact of changing regulations on submission strategies and update internal stakeholders
· Monitor applications under regulatory review
· Communicate application progress to internal stakeholders
· Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
· Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
· Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
· Provide strategic input and technical guidance on regulatory requirements to development teams
· Manage and execute preapproval compliance activities
Minimum Bachelor's degree. Bachelor's degree in science, 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 4-5 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.
Class III medical device experience (PMA or Design Dossier) strongly preferred. Combination drug/medical device product experience a plus.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org