Regulatory Affairs & Quality Manager

Janco, Inc.•Rollinsford, NH

1d•Onsite

About The Position

The Regulatory Affairs & Quality Manager will oversee the daily workflow, scheduling, assignments, training, and projects of the quality department and its employees. This role is responsible for ensuring production volumes, efficiency, and quality standards are met continuously and consistently. The manager will collaborate with other departments to prepare and implement strategic action plans, manage costs, ensure compliance with codes, guidelines, best practices, and policies, and troubleshoot problems. Key responsibilities include acting as the regulatory and ISO representative, developing and maintaining the QMS and QSMR, managing clean room certifications, performing audits, reporting on key performance metrics, and creating/maintaining vendor relationships. This is a full-time, salaried position working Monday through Friday, 8 am - 5 pm, on-site.

Requirements

Knowledgeable in ISO 13485.
Knowledgeable in EQMS.
Proficient with Microsoft Office Suite or related software as required to complete and maintain records.
Excellent verbal and written communication skills.
Excellent organizational skills and attention to detail.
Excellent time management skills with a proven ability to meet deadlines.
Strong analytical and problem-solving skills.
Project planning and management.
Good work ethic and positive attitude.
Valid Driver’s License.

Nice To Haves

Bachelor's degree preferred.

Responsibilities

Oversee the daily workflow, scheduling, assignments, training, and projects of the quality department and its employees.
Ensure production volumes, efficiency, and quality standards are met continuously and consistently.
Collaborate with other appropriate management staff to prepare and implement a strategic action plan and cost estimates of materials, time, labor, and other resources required to complete projects.
Ensure compliance with codes, guidelines, best practices, and policies.
Collaborate with fellow departments to identify and troubleshoot problems.
Act as regulatory representative and maintain FDA establishment registration.
Develop, maintain, and implement QMS manual, procedures, forms, and databases.
Maintain and implement QSMR policies, processes, and procedures.
Act as ISO representative and maintain ISO certification, training, and records.
Manage and maintain clean room certification, testing, monitoring, equipment, and packaging processes.
Perform audits.
Report key performance metrics and quality objectives.
Create and maintain vendor relationships and contracts.
Perform other related duties as assigned.