Regulatory Compliance Engineer, this position is for Abbott Vascular Division, located in Coyol, Alajuela, Costa Rica.
Main Purpose of role
As REGULATORY COMPLIANCE ENGINEER the employee with knowledge in the specific areas of Quality, Regulatory Compliance, CAPA and GMPs.
Performs assessments of site execution to requirements of the Abbott Vascular quality systems and Corporate Policies to ensure the site is working in compliance to these established requirements.
Their leadership in the area of CAPA compliance will assure the activities are performed and documented per our systems and procedures in accordance with Abbott policies and applicable quality and regulatory requirements intended to assure the effectiveness and safety of our products.
The employee will provide through key process indicators, the compliance status of the site and will lead initiatives needed to improve and sustain any process indicator that requires improvement.
The employee will have the ability to execute specialized projects and complex CAPAs related to the execution of the quality system.
Prepare content and serve as Meeting Facilitator for the Site Quality Data Review meeting ensuring compliance to the divisional requirements for the execution of this meeting.
Provide periodic updates of the site quality and compliance risks using process indicators results, and lead the teams in the completion of activities to minimize any risk as needed (e.
g. Quality Operations Meeting)
Conduct internal compliance inspections (walks / Audits / assessments)
Monitors compliance with company policies, procedures and regulations (e.g. AV QS documents, Abbott Policies and compliance with FDA, BSI regulations, etc.)
Identify and address recurring problems either with the quality of the product or compliance to policies, procedures or regulations.
Participate on Divisional Compliance Teams for coordination of site activities and provides direction to site audit team.
Problem solving and decision making for investigations and documentation of these within the applicable quality system.
Lead and support quality system projects at site level and may support projects at Divisional level
Perform Certificates of Compliance.
As requested, communicates product actions and subsequent updates to regulatory bodies. Including evaluation of health hazards for distributed product.
Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
Minimum Education and Experience required
Bachelor Degree in STEM related field in Engineering.
3 years of prior experience in Medical devices industries with a strong understanding of specified functional area, or an equivalent combination of education and work experience.
Language Proficiency : Fully Bilingual (English and Spanish) / Required
Preferred Qualifications & Education
2+ years in Quality, Compliance or Regulatory Affairs is desirable.
Experience in an audit environment is desirable.
The individual must understand a variety of quality / operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.
Additionally, must comply with :
The individual must have excellent oral / written communications skill.
Personal skills / key competencies needed include leadership, organization, ability to challenge systems, problem solving, attention to details, project management, ability to negotiate, time management, open-mindedness, maturity, tenacity, decisiveness, self-reliance and sound judgment.
Proficient in Microsoft Excel, PowerPoint, Word and Power BI
Licenses and certifications : Lead auditor ISO 13485 (desired), The Quality System Regulation 21 CFR 820 (desired), ANSI / AAMI / ISO 13485 : Navigating Regulatory Requirements (desired).