Director, Quality & Regulatory Affairs

Arteriocyte Medical Systems, Inc. d/b/a Isto Biologics, in Hopkinton, MA, has an opening for a Director, Quality & Regulatory Affairs. Work from home flexibility 2 days per week. Anticipated 10% domestic travel to other Arteriocyte Medical Systems, Inc. manufacturing facilities.

The Director, Quality & Regulatory Affairs oversees and manages all regulatory and quality materials and executes the strategy to ensure the company’s compliance with all applicable regulations, including but not limited to – FDA Quality System Regulations, ISO 13485, MDSAP, EU MDR Regulations, and related domestic and international regulations.

Duties and Responsibilities

Represents the company and liaises with the FDA, notifies body and other Regulatory Agencies ensuring the proper processes and policies and procedures relative to GMPs, GTPs and GLPs to obtain necessary regulatory approvals and maintains regulatory compliance.
Responsible for quality and timeliness of regulatory submissions (510K, PMA, Technical Files, IDE, IND, ANDA, Supplements, Device Listings etc.).
Attends project team meetings and collaborates with other functional areas for product development.
Performs internal audits on QMS processes and represents company for external audits.
Monitors external regulatory developments, identifies risks and communicates potential issues to senior management.
Advises and reviews the regulatory pathway for international product registration.
Reviews and approves technical data authored by R&D, Engineering, Marketing, Clinical or other related departments for the regulatory submission.
Monitors and ensures the timely renewal of licenses, certifications and permits.
Interprets existing or new quality or regulatory requirements.
Manages relationships within the relevant regulatory agencies to improve the quality of submissions.
Reviews and responsible for product recalls, advisory notices, field actions, regulatory reporting, CAPA investigations, and risk assessments.
Maintains an effective organization by selecting, developing and managing employees to achieve company quality objectives and compliance with regulations.
Reviews the investigation and addresses any reported issues of non-compliance.
Responsible for Medical Device Reporting for any adverse events reported.
Develops and/or revises the existing policies and procedures to ensure compliance with regulations.
Reviews and advises on marketing, sales, product claims, labeling, training materials and other materials to ensure practices are in conformance with regulatory requirements.
Oversees and maintains quality objectives and compliance requirements in their department by developing staff in regulatory matters, but will also continue to be a significant contributor to the company’s regulatory strategy as well.

Required Education and Experience

Master’s degree in Pharmaceutical, Biology, Life Sciences, Regulatory Affairs, or a related degree (foreign equivalent degree accepted) plus 5 years in global medical device registration and product lifecycle maintenance OR Bachelor’s degree in Pharmaceutical, Biology, Life Sciences, Regulatory Affairs, or a related degree (foreign equivalent degree accepted) plus 8 years of progressive, post-degree experience as a Regulatory Affairs or closely related role in the medical device industry.
5 years of experience in global medical device registration and product lifecycle maintenance.
3 years of experience in each of the following:
- Registration of Human cell and tissue (HCT) products and maintaining Tissue Bank license;
- Working with ANDA-approved product(s);
- Product complaint investigation and CAPA management; and
- Maintaining Quality Management System (QMS) and participated as lead auditee for QMS audits.

Experience may be gained concurrently.

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Director, Quality & Regulatory Affairs

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