Veterans at Abbott
Abbott Senior Regulatory Affairs Specialist in Santa Clara, California
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 103,000 colleagues serve people in more than 160 countries.
This Senior Regulatory Affairs Specialist position supports Abbott Structural Heart's MitraClip and Tricuspid valve medical device products . This role is focused on leading and supporting major projects; specifically, new product submissions, re-registrations, maintenance etc. for our class III products. We are ideally looking for someone with significant PMA submissions experience; medical device experience is a must have. Design Dossier or IDE submission experience would be a preference as well. This is an exciting role where you will work on complex regulatory submissions for a variety of major geographical areas.
Primary Job Function:
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
· Assist in SOP development and review
· Provide regulatory input to product lifecycle planning
· Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
· Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
· Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
· Determine trade issues to anticipate regulatory obstacles
· Determine and communicate submission and approval requirements
· Participate in risk-benefit analysis for regulatory compliance
· Assess the acceptability of quality, preclinical and clinical documentation for submission filing
· Compile, prepare, review and submit regulatory submission to authorities
· Monitor impact of changing regulations on submission strategies
· Monitor applications under regulatory review
· Monitor and submit applicable reports 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
· Maintain annual licenses, registrations, listings and patent information
· Assist compliance with product postmarketing approval requirements
· Review and approve advertising and promotional items to ensure regulatory compliance
· Assess external communications relative to regulations
· Review regulatory aspects of contracts
· Assist with label development and review for compliance before release
· Submit and review change controls to determine the level of change and consequent submission requirements
· Analyze the input of cumulative product changes to current product submissions
· Contribute to the development and functioning of the crisis/ issue management program
· Ensure product safety issues and product-associated events are reported to regulatory agencies
· Provide regulatory input for product recalls and recall communications
Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Note: Higher education may compensate for years of experience.
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