Regulatory Affairs Specialist - Vascular (on-site)

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.

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 passionate, experienced Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will support EU and US regulatory activities and collaborate with the global regulatory organization to maintain regulatory compliance for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities. This role requires strong attention to detail, technical competence, and effective communication skills to collaborate across multiple functional areas to ensure regulatory considerations are integrated throughout the product lifecycle. Proven successful track record of preparing submissions and documentation in compliance with relevant medical device regulations is preferred.

What You'll Work On

• Evaluate regulatory impact and develop global regulatory strategies to support product lifecycle management activities.
• Prepare and support regulatory submissions for Vascular devices to achieve departmental and organizational objectives.
• Assess proposed product, manufacturing, supplier, process, and labeling changes to determine regulatory impact and submission requirements across global markets.
• Develop and document regulatory assessments supporting design control and change management activities.
• Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities.
• Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
• Support maintenance of regulatory approvals and registrations for commercially marketed products.
• Support the product release process by collaborating with the Regulatory Operations team and ensuring products are released in a compliant and timely manner to support Abbott customers.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities as assigned.

Required Qualifications

• Bachelor's degree (or equivalent)
• 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. Note: Higher education may compensate for years of experience.
• Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Preferred Qualifications

• Bachelor's degree in science (biology, chemistry, microbiology, etc.), engineering, or biomedical fields.
• Master's degree in Regulatory Affairs.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Experience within the medical device industry, particularly supporting Class II and/or Class III products.
• Experience supporting commercially marketed medical devices, including post-market compliance and regulatory maintenance activities.
• Experience authoring or supporting regulatory submissions and regulatory strategies that resulted in successful regulatory outcomes.
• Experience with U.S. regulatory submissions, including Traditional, Special, and Abbreviated 510(k)s, PMAs, and PMA supplements.
• Experience with EU MDR (2017/745) Technical Documentation and change assessments.
• Working knowledge of medical device regulations and international standards, including ISO 13485, and ISO 14971.
• Experience conducting regulatory assessments associated with design, manufacturing, supplier, labeling, and process changes.
• Experience with risk management activities and documentation in accordance with ISO 14971.
• Experience working within medical device quality systems and design control environments.
• Experience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, and change control processes.
• Ability to work effectively in a highly matrixed and geographically diverse organization.
• Experience with cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies is preferred.

The base pay for this position is $81,500.00 $141,300.00. In specific locations, the pay range may vary from the range posted.