Regulatory Affairs Senior Manager - Santa Clara, United States - Abbott Laboratories

Description

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 114,000 colleagues serve people in more than 160 countries.

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
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the student debt program and 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

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

This Regulatory Affairs Senior Manager position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division. The candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. This new team member has department/group/site level influence and is generally recognized as an expert resource and mentor within the department.

WHAT YOU'LL DO

• Provide regulatory input to product lifecycle planning. Provide strategic input and technical guidance on regulatory requirements to development teams
• Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
• Support pre and post approval clinical strategy and submission activities
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• Assess the acceptability of development, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Ensure compliance with US and global product post marketing approval requirements
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
• Execute and manage technical and scientific regulatory activities. Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.
• Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
• Provide leadership and guidance towards achieving department objectives and act as a mentor to less-experienced staff
• May supervise exempt or non-exempt employees
• May lead a cross-functional or cross-divisional project team
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures

Required Qualifications

• Bachelor's Degree in a related field OR an equivalent combination of education and work experience
• Minimum 9 years related experience.
• Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
• Monitors costs of projects and of human and material resources within a department or unit.
• Monitors company-wide indicators such as market share and profitability.
• Monitors external environment in area of technical or professional responsibility.
• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.
• Facilitates others' participation in the continuous improvement program.
• Investigates and solves problems that impact work processes and personnel within or across units or departments.
• Develops and communicates a vision for the organizational unit assigned.

Preferred Qualifications

• Bachelor's degree in science, math, engineering, or medical fields.
• Master's or Ph.D. in a technical area
• Previous experience with PMA / IDE and international submissions
• Experience with combination product and/or Class III medical devices
• Experience with IDE trial strategy and post market clinical activities
• Ability to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Experience with post-approval manufacturing and design changes
• Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
• Ability to work effectively on cross-functional teams
• Strong attention to detail
• Experience with organizing and tracking complex information. Able to juggle multiple and competing priorities
• Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business
• Uses in-depth knowledge of business functions and cross group dependencies/ relationships

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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

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 , on Facebook at and on Twitter @AbbottNews.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $125,700.00 – $251, In specific locations, the pay range may vary from the range posted.