Abbott Principal Regulatory Affairs Specialist in Pleasanton, 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.
As an individual contributor, the function of a Regulatory Affairs Project Manager/Principal Specialist 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:
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 cardiovascular devices (Class III active implantables) product lifecycle planning.
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.
Assist in the development of multi- country 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 global pre-market and post-market regulatory submissions (including PMAs, IDEs, HDEs, etc.) 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 new product development and sustaining teams.
Manage and execute preapproval compliance activities.
Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
Ensure compliance with product post marketing approval requirements.
Ensure external communications meet regulations.
Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events
Actively contribute to the development and functioning of the crisis/issue management program.
Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
Report adverse events to regulatory agencies and internal stakeholders.
Provide regulatory input for product recalls and recall communications.
Review and approve advertising and promotional items to ensure regulatory compliance.
Individuals execute and manage technical and scientific regulatory activities.
Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met.
Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.
Properly interpret and apply regulatory requirements.
Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments.
Completed work is reviewed from a relatively long- term perspective for desired results.
Individual is recognized as a discipline expert and resource in regulatory affairs.
Bachelor's degree (or equivalent), 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).
5-8 years of experience in regulatory affairs preferred, but may consider affairs, operations, or related area. 8-10 years’ experience in a regulated industry (e.g., medical products, nutritionals). Experience in cardiovascular or other active implantable devices preferred.
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 email@example.com