Principal Regulatory Affairs Specialist – Vascular (on-site)

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
• 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

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 Principal Regulatory Affairs Specialist position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position 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. Supports necessary regulatory activities required for product market entry. The individual may execute tasks and play a consultative role by partnering across business functions.  The individual may assist in identifying data needed, obtaining these data, and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

WHAT YOU’LL DO

Strategic Planning:

• Provide regulatory input to product lifecycle planning.
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
• Determine trade issues to anticipate regulatory obstacles.
• Determine and communicate submission and approval requirements.
• Participate in risk-benefit analysis for regulatory compliance.

Premarket:

• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Compile, prepare, review and submit regulatory submissions to authorities.
• Monitor impact of changing regulations on submission strategies.
• Monitor applications under regulatory review.
• Monitor and submit applicable reports to regulatory authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

Postmarket:

• Maintain annual licenses, registrations, and listings
• Create, update and maintain EU technical documents.
• Assist in compliance with product post-marketing approval requirements.
• Assess external communications relative to regulations.
• Review regulatory aspects of contracts.
• Assist with label development and review for compliance before release.
• Submit and review change controls to determine the level of change and consequent submission requirements.
• Analyze the input of cumulative product changes to current product submissions.
• Ensure product safety issues and product-associated events are reported to regulatory agencies.
• Provide regulatory input for product recalls and recall communications.

Required Qualifications

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
• Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.
• Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
• Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.

Preferred Qualifications

• Bachelor's degree in science/technical discipline (engineering, life sciences, mathematics).
• Minimum of 5 years’ experience working with Class II and/or Class III medical devices.
• Previous experience with 510(k) or PMA/IDE and international submissions.
• Experience with on market product change assessment
• Experience with EU MDR technical documentation maintenance and updates
• Experience with US, EU and OUS submissions and product registrations
• 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, manage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in a timely manner.
• Experience working in the Medical Device industry.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Apply Now

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 $98,000.00 – $196,000.00. In specific locations, the pay range may vary from the range posted.