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

Abbott Laboratories; Pleasanton (CA); On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott Laboratories in Pleasanton, CA is seeking a Regulatory Affairs Specialist II to work on-site. The role involves preparing regulatory submissions for FDA and international agencies and supporting product release with regulatory documentation.

You will interact with cross-functional teams to ensure compliance and timely submissions. The ideal candidate holds a Bachelor's degree with at least 2 years in a regulated industry, strong communication skills, and the ability to work in a

Qualifications

• 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, pharma) or related area.
• Strong verbal and written communications; ability to communicate at multiple levels.
• Work with cross-functional teams and diverse cultures.
• Negotiate internally and exercise judgment within defined practices.
• Attention to detail and ability to manage complex information.
• Regulatory ethics standards and teamwork in a fast-paced environment.

Responsibilities

• Prepare regulatory applications for FDA or international agencies.
• Review and approve engineering changes and regulatory assessments.
• Interface with FDA and other regulatory bodies as needed.
• Support product release with regulatory documentation and licenses.
• Ensure compliance with FDA and international regulations across submissions.
• Assist in maintaining QMS/EMS aligned with regulatory requirements.

Skills

Verbal communication

Cross-functional

Attention to detail

Analytical thinking

Education

Bachelor's degree

Master's degree

Job description

Working at Abbott

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. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

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

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.

What You’ll Work On

• 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.

Required Qualifications

• 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. Note: Higher education may compensate for years of experience.
• 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.

Preferred Qualifications

• 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $81,500.00 – $141,300.00. In specific locations, the pay range may vary from the range posted.