Senior Regulatory Specialist

Senior Regulatory Affairs Specialist

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 115,000 colleagues serve people in more than 160 countries.

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.

The Opportunity

This Senior Regulatory Affairs Specialist will work out of our Pleasanton, CA location in the Heart Failure Division. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department. With limited supervision you will execute tasks and partner across business functions.

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities.

What You'll Work On

• As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interacts with FDA and other regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management.
• Ensures timely approval of medical devices and continued approval of marketed products.
• Interfaces directly with FDA and other regulatory agencies.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Creates, reviews and approves engineering change orders.
• 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.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Required Qualifications

• Bachelors Degree ( 16 years) Technical discipline highly preferred OR an equivalent combination of education and work experience
• Minimum 5 years Technical experience, including at least 4 years of regulatory experience in a medical device industry.
• Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
• 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.
• Strong verbal and written communication with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organization and follow-up skills, as well as attention to detail.
• Ability to travel approximately 5%, including internationally.

Preferred Qualifications

• Masters Degree ( 18 years), In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience. Minimum 3 years, 3-4 years 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. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Experience with review of labeling, promotional, and or advertising materials is highly desired
• Familiar with Principles and requirements of promotion, advertising and labeling.
• Office program skills to include Word, Excel, PowerPoint, Adobe Acrobat and SharePoint.
• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields. Master's Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.

The base pay for this position is $90,000.00 $180,000.00. In specific locations, the pay range may vary from the range posted.