Principal Regulatory Affairs Specialist – Vascular (on-site)

About the role

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.

Responsibilities

• 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.
• 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.

Requirements

• 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).

Pay

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.