Principal Regulatory Affairs Specialist Vascular (on-site)

Principal Regulatory Affairs Specialist

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 115,000 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.

The Opportunity

Abbott is seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will provide regulatory leadership for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease and support global regulatory strategies throughout the product lifecycle. The Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. This individual will serve as a key regulatory partner to cross-functional teams and contribute to strategic decision-making by interpreting regulatory requirements, evaluating business risks, and developing practical regulatory solutions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.

What You'll Work On

• Develop and execute global regulatory strategies to support product changes, manufacturing transfers, lifecycle management activities, new product development, and business objectives.
• Independently prepare regulatory submissions and documentation for medical devices.
• Lead regulatory assessments for design, manufacturing, supplier, labeling, and process changes to determine global regulatory requirements and submission strategies.
• Review and approve engineering change orders, protocols, reports, specifications, risk management documentation, validation documents, and other project-related records.
• Support and maintain U.S. and international product registrations, licenses, approvals, and technical documentation throughout the product lifecycle.
• Serve as the regulatory lead on cross-functional project teams, providing strategic guidance throughout product development and commercialization activities.
• Interpret and apply global regulatory requirements, standards, guidance documents, and industry best practices to support business needs.
• Prepare and maintain FDA submissions, including 510(k)s, PMAs, PMA supplements, and other required submissions, as applicable.
• Support EU MDR regulatory activities, including Technical Documentation updates, change assessments, and notified body interactions.
• Collaborate with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, Supply Chain, Marketing, and other functional groups to ensure timely execution of regulatory deliverables.
• Analyze evolving regulatory requirements and provide recommendations regarding business impact, compliance risks, and implementation plans.
• Support regulatory authority and notified body inspections, audits, inquiries, and responses.
• Support all company initiatives in accordance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and applicable regulatory requirements.
• Maintain compliance with FDA regulations, international regulations, company policies, procedures, and quality requirements.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Act as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
• May manage direct reports or serve as mentor to other regulatory affairs specialists
• Perform other duties and responsibilities as assigned.

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).

Preferred Qualifications

• 6-8 years experience in medical device industry with experience working with Class II and/or Class III devices.
• Regulatory affairs professional experience supporting medical devices.
• Experience leading regulatory activities for cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
• Has a strong attention-to-detail
• Strong written, verbal, presentation, and organizational skills as well as analytical and problem-solving skills.
• Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
• Experience authoring and submitting Traditional, Special, or Abbreviated 510(k)s; PMAs; PMA supplements; IDEs; or other FDA submissions.
• Experience supporting EU MDR (2017/745) Technical Documentation, change notifications, clinical evaluation documentation, or notified body interactions.
• Knowledge of global regulatory requirements and submission pathways outside the United States and European Union; in particular highly regulated countries such as China, Canada, Australia, or Brazil.
• Experience participating in regulatory authority inspections, notified body audits, and responses to regulatory inquiries.
• Experience reviewing risk-based regulatory assessments and supporting product risk management activities in accordance with ISO 14971.
• Experience reviewing clinical data.
• Experience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, eQMS platforms, and change control processes.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work effectively within a team and as an individual contributor in a fast-paced, changing environment.
• Experience managing direct reports or dotted line manager to regulatory affairs specialists
• Ability to leverage, manage and/or engage others to accomplish projects.
• Applies critical thinking to multitask, prioritize and meet deadlines in a timely manner.
• Ability to identify risk areas and escalate issues as appropriate.

The base pay for this position is $100,000.00 $200,000.00. In specific locations, the pay range may vary from the range posted.