Senior Regulatory Affairs Specialist – Heart Failure (on-site)

Abbott • Pleasanton, CA

92d • $86,700 - $173,300

About The Position

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. You’ll also have access to career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. Our mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment.

Requirements

• Bachelor's Degree in a related field OR an equivalent combination of education and work experience.
• 3-4 years of experience in a regulated industry (e.g., medical products, nutritionals).
• 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
• Strong organizational and follow-up skills, as well as attention to detail.
• Organize and track complex information.
• Exercise good and ethical judgment within policy and regulations.
• Use in-depth knowledge of business functions and cross group dependencies/relationships.
• Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.

Nice To Haves

• Minimum of 5 years’ experience working with Class II and/or Class III medical devices.
• Regulatory Affairs Certification (RAC) is a plus.
• Experience with either 510(k) applications, PMA supplements and US device regulations, or with EU and other international medical device regulations and submissions.
• Must be familiar with relevant 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.
• Ability to identify, solve problems, and work independently with little oversight.
• 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.

Responsibilities

• Develops worldwide strategies for regulatory approval of new and modified products.
• Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives.
• Coordinates, compiles, and submits regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations.
• Represents Regulatory Affairs on cross-functional product development and manufacturing support teams.
• Guides teams to provide content for submissions and participates in design reviews as needed.
• Maintains annual licenses, registrations, and listing information.
• Assists with compliance to product post-marketing approval requirements.
• Acts as Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities.
• Reviews, edits, and approves Advertising and Promotional materials.
• Acts as liaison between the Company and in-country affiliates as well as the various regulatory agencies.
• Maintains ongoing surveillance and analysis of all pertinent medical device regulations.
• Supports the product implementation process by creating database (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 maintains productive, constructive relationships with external customers.
• Supports Department and Company initiatives as identified by management.
• Complies with US Food and Drug Administration (FDA) and international regulations, company policies, operating procedures, processes, and task assignments.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan.
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees