Regulatory Affairs Specialist II Cardiac Rhythm Management
1 week ago
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 114,000 colleagues serve people in more than 160 countries. At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self, and live a full life.
What You'll DoAs a Regulatory Affairs Specialist II, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
You will support necessary regulatory activities required for product market entry, preparing robust regulatory applications, creating, reviewing, and approving engineering changes, and acting as a core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
You will also review and evaluate communications to ensure they convey all necessary detail and adhere to applicable regulatory standards, including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
Maintaining pertinent domestic and international medical device regulations to ensure submission requirements worldwide are current, up-to-date, and entered into regulatory submission data base and file systems.
You will ensure that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
May interface directly with FDA and other regulatory agencies. Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
Reviews protocols and reports to support regulatory submissions. Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
RequirementsWe are looking for a highly skilled and experienced Regulatory Affairs Specialist II to join our team. The ideal candidate will have a Bachelor's degree or an equivalent combination of education and work experience, with a minimum of 2 years of experience in a regulated industry, preferably in regulatory affairs.
The candidate should have strong verbal and written communication skills, with the ability to effectively communicate at multiple levels in the organization. Multitasking, prioritizing, and meeting deadlines in a timely manner are essential skills for this role.
The candidate should also have strong organizational and follow-up skills, as well as attention to detail. Experience with submission/registration types and requirements, as well as knowledge of regulatory guidelines and standards, is highly desirable.
Certification as a Regulatory Affairs Professional (RAC) from the Regulatory Affairs Professionals Society is a plus. The candidate should be able to work in a highly matrixed and geographically diverse business environment, with the ability to leverage and/or engage others to accomplish projects.
Experience working in a broader enterprise/cross-division business unit model, as well as experience working in the Medical Device industry, is highly desirable. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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Los Angeles, California, United States Abbott Laboratories company Full timeAbout Abbott LaboratoriesAbbott 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 114,000 colleagues serve people in more than...
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