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

Abbott • Pleasanton, CA

8d • Onsite

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 122,000 colleagues serve people in more than 160 countries. At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Abbott’s Heart Failure (HF) business pioneers and increases 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. We are presently hiring for a Regulatory Affairs Specialist II to work on-site at our Pleasanton, CA location. This new team member performs 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. Additionally, will support necessary regulatory activities required for product market entry.

Requirements

• Bachelor's degree or an equivalent combination of education and work experience
• Minimum of 2 years’ experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Write and edit technical documents.
• Work with cross-functional teams.
• Work with people from various disciplines and cultures.
• Negotiate internally.
• Pay strong attention to detail.
• Ability to leverage, manage and/or engage others to accomplish projects.
• Think analytically and critically.
• Organize and track complex information.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Apply business and regulatory ethical standards.
• Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
• Ethical guidelines of the regulatory profession, clinical research and regulatory process.

Nice To Haves

• Higher education may compensate for years of experience.
• Bachelor’s Degree In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields
• Master’s degree
• Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
• 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.
• Strong organizational and follow-up skills, as well as attention to detail.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Experience working in the Medical Device industry.
• Regulatory Affairs Professionals Society Certification is a plus.

Responsibilities

• Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering changes.
• Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
• Reviews and evaluates communications to ensure communications 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.
• Maintains pertinent domestic and 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.
• 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.
• Complies with U.S. Food and Drug Administration (FDA) and 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.

Benefits

• 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 a 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level