Regulatory Affairs Specialist II Structural Heart
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.
We have a team of 114,000 colleagues serving people in more than 160 countries. Our mission is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
The OpportunityWe are recruiting for a Regulatory Affairs Specialist II to join our team on-site in Santa Clara, CA. This new team member will support manufacturing/operations day-to-day activities for change control and provide regulatory direction on team activities.
The individual will apply basic regulatory understanding to support product and teams, prepare US/CE regulatory submissions and/or registration documents for international affiliates and government agencies worldwide, and handle regulatory activities involved in documentation, labeling, field support, and apply regulatory and technical knowledge to a focused area of work assignments.
This Specialist will understand, implement, and maintain the quality policy and ensure compliance to and demonstrate knowledge of site and division level policies and procedures.
What You'll Work On- Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance, project plans.
- Implements Division Regulatory Strategy in specific product-related activities.
- Basic understanding of laws and regulations.
- Obtains supervisory input for interpretation leading to the solution of issues, and to product development and support.
- Analyzes the input of cumulative product changes to current product submissions.
- Shares knowledge with others in department and on teams.
- Provides solutions to a variety of problems where analysis requires moderate degree of evaluation.
- Prepares and aligns individual goals with department goals.
- Establishes and executes against project goals and implements plans.
- Provides input to establishing group plans and implementation of those plans.
- Follows GMP guidelines and procedures.
- Bachelor's Degree or an equivalent combination of education and experience.
- 5 years of work experience.
- Preferred qualifications include a Bachelor's degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, engineering, etc., 5+ years of experience in the Medical Device industry, 1-2 years of regulatory experience, and RAPS Certification.
Abbott is an Equal Opportunity Employer, committed to employee diversity. We offer a competitive salary and benefits package, including a comprehensive health insurance plan, retirement savings plan, tuition reimbursement, and education benefits. Apply now to join our team and take the first step towards a rewarding career with Abbott Laboratories company.
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Santa Clara, California, United States Abbott Laboratories company Full timeAbout Abbott LaboratoriesAbbott Laboratories 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 MissionOur business purpose is...
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