Abbott Senior Specialist, International Regulatory Affairs 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 in our Cardiac Arrhythmias & Heart Failure regulatory affairs team (medical devices), the function of a Senior Specialist, International Regulatory Affairs 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.
Develops international strategies for regulatory approval of company products.
Coordinates, compiles and submits international regulatory submissions, including filing and/or creation of Dossiers, Premarket Notifications, Supplements, Change Notifications, and other country-specific product registrations.
Prepares robust regulatory applications to achieve departmental and organizational objectives.
Represents international regulatory affairs on project planning and cross-functional project teams. Guide teams to provide content for international submissions, participates in design reviews as needed.
Acts as liaison between the Company and in-country affiliates/the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.
Maintains ongoing surveillance and analysis of all pertinent international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
Interfaces directly with regulatory agencies as needed.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Bachelor’s degree; Bachelor’s degree in life sciences, engineering, or other technical discipline is preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Three to five years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Minimum of 2 years of experience in international regulatory affairs in medical device industry. Ideally have knowledge of regulatory requirements in accordance with international medical device regulations (in APAC, ANZ, LA, EMEA, etc.) and other relevant regulations, international standards and guidance documents.
Experience with word processing, spreadsheet and presentation graphic software packages is required.
Experience working in a broader enterprise/cross-division business unit model
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes and meets deadlines in a timely manner.
Strong organizational and follow-up skills, as well as attention to detail
Ability to travel approximately 5%, including international travel
Ability to maintain regular and predictable attendance
Ability to identify and solve problems and work independently with little oversight
Ability to speak another language 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 email@example.com