Regulatory Affairs Specialist II

Working at Abbott

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. 

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
  

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. 

WHAT YOU’LL DO

We are recruiting forRegulatory Affairs Specialist II to join our team in the Pleasanton, CA location. In this role, you will provide support for the regulatory department to ensure efficient and compliant business processes and environment.  You will play a consultative role by partnering across business functions assisting in identifying data needed, obtaining required documentation, and ensuring that submissions are effectively presented for the registration of products worldwide.  You may be preparing and/or submitting documentation needed for worldwide registration. 

Responsibilities:

• Authors, coordinates, compiles and submits international regulatory submissions, including filing and/or creation of Technical Documentation, Premarket Notifications, Supplements, Change Notifications, and other product registrations.

• Prepares robust regulatory applications to achieve departmental and organizational objectives

• Represents RA on cross-functional product development and manufacturing support teams.

• Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.

• Maintains ongoing surveillance and analysis of all pertinent 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.   

• Interfaces directly with regulatory agencies as needed.

• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.

• Communicates with and maintain productive, constructive relationships with external customers as required – regulatory authorities and notified-bodies,

• Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Complies with 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

• Bachelors Degree (± 16 years), in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience

• Master's Degree (± 18 years), Preferred

• Minimum 2 years This position does not require previous regulatory experience. 2-3 years' experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area

• Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel;  Principles and requirements of applicable product laws;  Submission/registration types and requirements;  GxPs (GCPs, GLPs, GMPs);  Principles and requirements of promotion, advertising and labeling;  Domestic and international regulatory guidelines, policies and regulations;  Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.

• Communicate effectively verbally and in writing.  Communicate with diverse audiences and personnel.  Write and edit technical documents.

• Work with cross-functional teams.  Work with people from various disciplines and cultures.

• Write and edit technical documents. 

• Negotiation skills. 

• trong attention to detail. 

• Manage projects. Create project plans and timelines.

• 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.

• Has a sound knowledge of a variety of alternatives and their impact on the business

• Apply business and regulatory ethical standards.

Preferred

• Bachelor’s degree in a technical discipline

• 3+ years of related regulatory submission experience from a medical device and/or pharmaceutical industry 

• Familiar with relevant US/ EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations

• Proficient with MS Office suite (Word, Excel, Outlook)

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.  

• Advanced level degree

• Previous experience working in a highly matrixed and geographically diverse business environment

WHAT WE OFFER 

At Abbott, you can have a good job that can grow into a great career. We offer: 

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans  

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs 

• Paid time off

• 401(k) retirement savings with a generous company match 

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.