Regulatory Affairs Operations Specialist

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.

The Opportunity –

We are seeking a highly organized and proactive Regulatory Operations Specialist for our Santa Clara, CA location to perform specialized level work assignments and/or analyses, evaluation, preparation and general support of global regulatory activities. As an individual contributor, the Regulatory Operations Specialist will play a crucial role in ensuring efficient and compliant business processes within the regulatory affairs department. The function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide coordinate emerging regulatory issues and trends for the regulatory affairs department.

MAIN RESPONSIBILITIES

• Coordinate emerging regulatory issues and trends in global geographies and translate regulatory requirements into the quality system.

• Monitor changing regulations and new regulatory requirements and implement necessary updates to internal procedures.

• Provide regulatory input to product lifecycle planning. • Oversee the regulatory affairs program for monitoring, reporting, and analyzing emerging issues; and enter new requirements into the regulatory tracker.

• Organize and lead quarterly review meetings for the emerging issues program to track adherence to conformance dates.

• Drive quality system process improvement initiatives (e.g. change management).

• Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.

• Determine trade issues to anticipate regulatory obstacles. Participate in risk benefit analysis for regulatory compliance.

• Determine and communicate submission and approval requirements. Monitor applications under regulatory review.

• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

• Assist in preparation and review of regulatory submission to authorities.

• Maintain annual licenses, registrations, listings and patent information.

• Assist compliance with product postmarketing approval requirements. Assist in the review of advertising and promotional items.

• Assess external communications relative to regulations. Review regulatory aspects of contracts.

• Assist with pan-franchise requests, including but not limited to labelling development, regulatory letters, and review declarations of conformity for compliance before release.

• Submit and review change controls to determine the level of change and consequent submission requirements.

• Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product associated events are reported to regulatory agencies.

• Provide regulatory input for product recalls and recall communications.

• Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments. May lead a departmental project team.

• Establishes and cultivates an extensive network of support to facilitate completion of assignments.

• Participates in determining goals and objectives for projects.

• Influences middle management on technical or business solutions.

• May interact with vendors.

• Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.

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. Masters Degree (± 18 years) Preferred

• Minimum 2 years experience. 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.

• Negotiate internally.

• Pay strong 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.

• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Preferred Qualifications –

• Medical Device industry experience.

• Experience working in a broader enterprise/cross-division business unit model.

• Exceptional communication skills, both assertive and collaborative.

• Excellent organizational skills and attention to detail.

• Strong time management and prioritization abilities.

• Strong problem-solving skills and ability to think strategically and see the big picture.

• Adaptable with the ability to switch priorities and accomplish all tasks.

• Process oriented.

• Experience with quality system process improvements and change management.