Regulatory Manager responsible for developing global strategies for orthopedic implants at Acumed. Ensures compliance with regulatory applications and directs departmental projects.
About the role
- Director of Quality and Regulatory Affairs at PRC Saltillo ensuring quality and compliance with global regulatory standards. Leading quality initiatives and mentoring teams within the medical device industry.
Responsibilities
- Ensure a robust and compliant quality management system (QMS) aligned with ISO 13485, FDA/QMSR, EUMDR, and other applicable standards.
- Provide leadership and oversight to personnel serving as primary contacts for external audits, assessments, and inspections, ensuring ongoing audit readiness.
- Lead management review processes and ensure effective follow up on quality system performance and improvement initiatives.
- Oversee interpretation and implementation of regulatory, legal, customer, and industry quality requirements.
- Ensure effective and compliant training programs for employees at all levels on quality standards, procedures, and continuous improvement methodologies.
Requirements
- Bachelor’s degree in Engineering, Quality Management, Compliance, or a related field required.
- Minimum of five years of experience in regulatory affairs and quality management systems within medical devices or related industries required.
- At least three years of experience working with a document control system required.
- Demonstrated leadership and coaching skills with the ability to build and sustain a team-oriented culture.
- Strong analytical, organizational, and problem-solving skills.
- Advanced proficiency in Microsoft Office, particularly Excel, with the ability to analyze and present large datasets.
- Ability to effectively delegate, prioritize, and coordinate a wide variety of activities.
- In depth knowledge of medical device manufacturing compliance, quality systems, procurement, and shipping requirements.
- Strong relationship building skills with clients, colleagues, and vendors/suppliers.
- Excellent written, verbal, and interpersonal communication skills.
- Self-directed with the ability to perform effectively with minimal supervision.
- Collaborative team player able to work across all levels of the organization.
- Adaptable and flexible in a dynamic, evolving environment.
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