Sr. Regulatory Assurance/Quality Assurance Specialist

Job Description

Job Description

Location : Mansfield MA

Department : Regulatory Affairs Arterex Medical Consolidated Position

Reports To : Sr. VP Quality and Regulatory Affairs (Corporate)

Position Overview :

The Senior RA / QA Specialist will play a critical role in ensuring our medical devices meet international regulatory standards and quality requirements, inclusive of sterilization processes.

This individual will oversee regulatory compliance activities, manage documentation for product approvals, and ensure adherence to global regulatory standards, including ISO 13485 : 2016, FDA 21 CFR and sterilization standards.

The ideal candidate will have extensive experience in the medical device industry, inclusive of sterilization oversight, and a deep understanding of regulatory requirements across multiple regions.

Key Responsibilities :

• Regulatory Compliance :
• Ensure compliance with international regulatory requirements (e.g., FDA, EU MDR, Health Canada, TGA).
• Prepare and submit regulatory documentation and registrations for product approvals.
• Maintain current knowledge of relevant regulatory requirements, including sterilization standards and industry best practices.
• Review and approve regulatory submissions and documentation for accuracy and completeness.
• Sterilization Oversight :
• Oversee sterilization processes to ensure compliance with ISO 11135, ISO 11137, and other relevant standards.
• Coordinate and review validation and re-validation activities for sterilization processes.
• Develop and maintain sterilization procedures and protocols.
• Liaise with sterilization service providers to ensure compliance with regulatory and quality requirements.
• Quality Management System (QMS) :
• Support the development, implementation, and maintenance of the QMS in accordance with ISO 13485.
• Support internal audits to ensure compliance with QMS requirements.
• Lead continuous improvement initiatives within the QMS framework
• Product Lifecycle Management :
• Oversee regulatory aspects throughout the product lifecycle from development through post-market.
• Coordinate risk management activities in accordance with ISO 14971.
• Ensure proper documentation and validation of manufacturing and sterilization processes.
• Audits and Inspections :
• Prepare for and manage external audits and inspections by regulatory bodies.
• Implement corrective and preventive actions (CAPA) as needed.
• Maintain audit readiness and compliance with regulatory standards.
• Supplier and Vendor Management :
• Support the evaluation, qualification, and monitoring of suppliers and vendors to ensure compliance with quality and regulatory standards.
• Support oversight supplier audits and supplier quality performance, inclusive of sterilization service providers.
• Develop and maintain supplier quality agreements.
• Training and Mentorship :
• Provide training and support to staff on quality and regulatory requirements.
• Mentor junior associates regarding the quality / regulatory affairs discipline.
• Promote a culture of regulatory compliance and quality assurance across the organization.

Qualifications :

• Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree favorable.
• Minimum of 7-10 years of experience in regulatory affairs in the medical device industry, with a focus on sterilization processes.
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant international standards and regulations.
• Proven experience in leading internal and external audits.
• Strong understanding of sterilization standards (ISO 11135, ISO 11137) and risk management principles (ISO 14971).
• Excellent communication, organizational, and analytical skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Certification in quality management or regulatory affairs (e.g., CQE, RAC) is favorable.
• Ability to work effectively in a fast-paced, dynamic environment.

Work Environment :

• This position may require occasional travel to supplier sites, sterilization service providers, regulatory bodies, and other company locations.
• The role is primarily office-based but may involve visits to manufacturing and sterilization facilities.
11 days ago