Specialist II, International Regulatory Affairs
Description de l'offre
As an individual contributor, the function of a Specialist II, 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 RA on cross-functional product development and manufacturing support 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.
- Communicates with and maintain productive, constructive relationships with external customers as required – regulatory authorities, notified-bodies, in-country affiliates and/or distributors.
- 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.)
- A minimum of 3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Experience with international medical device regulations (in APAC, ANZ, LA, EMEA, etc.) and submissions.
- Must be familiar with relevant international regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
- Experience with word processing, spreadsheet and presentation graphic software packages is required.
- Experience working in a broader enterprise/cross-division business unit model preferred
- 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
JOB FAMILY:Regulatory Operations
DIVISION:CAHF Cardiac Arrhythmias & Heart Failure
LOCATION:United States > Pleasanton : 6035 Stoneridge Dr
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf