LL02-020524 Regulatory Compliance Analyst

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Regulatory Compliance Analyst

The scope involves providing crucial support to Regulatory affairs team concerning EU MDR certification and deficiency resolution within manufacturing operations on a global scale. This role requires monitoring compliance, managing documentation, and collaborating with various departments to maintain regulatory conformity.

Job Summary:

The Regulatory Compliance Analyst, reporting to Regulatory Compliance Manager – MDR at the Global Quality Assurance department, is instrumental in supporting global manufacturing operations’ regulatory compliance efforts with primary focus on aiding the Regulatory Affairs department with the EU MDR certification information and collaborating on deficiency resolution across manufacturing sites. This role involves analyzing, monitoring, and ensuring adherence to regulatory standards, working closely with sites cross-functional teams to maintain compliance.

Essential Functions & Accountabilities:

• Provide support to Regulatory Affairs team in compiling, organizing, and managing EU MDR certification-related information pertinent to manufacturing sites operations.
• Collaborate closely with cross-functional teams to aid in the identification and resolution of deficiencies related to regulatory compliance, ensuring timely and effective resolution.
• Conducting investigation to identify the root causes, developing, and implementing actions to address process related issues.
• Stay up to date on changes, conducting risk assessment / gap assessments to identify potential process related risks / gaps.
• Collaborate with multifunctional teams to identify and implement process improvements!
• Developing and implement SOPs to ensure consistent and reliable manufacturing operations processes.
• Ensuring that processes are efficient, effective, and compliant with regulatory requirements and standards.
• Providing training and guidance to employees regarding regulatory compliance.

Qualifications:

• Excellent knowledge of Medical Devices quality standards and regulations (GMPs/QSR).
• Excellent in oral/ written communication skills in both English and Spanish languages.
• Excellent interpersonal skills.
• Capable of managing multiple tasks and prioritizing own workload.
• Intermediate skill in the use of Excel, Word, and PowerPoint; advanced preferred.
• Excellent analytical and problem-solving skills.
• Strong organizational and time-management skills.
• Strong attention to detail.
• Knowledge of statistical methods.
• Training and education skills.
• Ability to read and understand highly technical material.
• Highly motivated, self-starter, and responsible person.
• Service oriented.

Experience:

• 5+ years or more experience in a medical device in a similar position.

Education:

• Bachelor’s degree in business administration or science or related experience in within compliance focus role.