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Regulatory Affairs Specialist II Heart Failure
2 months 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.
Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist II to join our Heart Failure Division in Pleasanton, CA. As a key member of our team, you will be responsible for ensuring that our products and procedures comply with regulatory agency specifications.
Key Responsibilities- Prepare and submit regulatory applications to achieve departmental and organizational objectives.
- Create, review and approve engineering changes.
- Act as a core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments.
- Review and evaluate communications to ensure they convey all necessary detail and adhere to applicable regulatory standards.
- Maintain pertinent domestic and international medical device regulations to ensure submission requirements are current and up-to-date.
- Interface directly with FDA and other regulatory agencies as needed.
- Bachelor's Degree or equivalent combination of education and work experience.
- Minimum 3 years related experience, including a minimum of 2 years regulatory experience.
- Experience with 510(k) applications, PMA supplements and US device regulations or EU and other international medical device regulations and submissions.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong verbal and written communications skills.
- Bachelor's Degree in a Science/Technical discipline (engineering, life sciences, mathematics).
- Masters degree.
- Experience working in a broader enterprise/cross-division business unit model.
- Regulatory Affairs Professionals Society Certification.
Abbott is an Equal Opportunity Employer, committed to employee diversity. We offer a competitive salary and benefits package, including medical coverage, retirement savings plan, and tuition reimbursement. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.
