Sr. Director/Head of Quality Assurance and Regulatory Affairs

Role Summary:

The Sr. Director/Head of Quality Assurance and Regulatory Affairs is responsible for overseeing and providing direction for the company's quality system and regulatory strategies as well as establishing long-term strategies to meet company goals.

Reporting to the Chief Operating Officer, this position will serve as an in-house champion on best practices for compliance and ensuring effectiveness of quality programs.

This is a hands-on role leading a small team where you will have the ability to make a large impact on our success.

Must have strong background in Quality Assurance and ability to grow in to managing Regulatory Affairs with support of existing Regulatory Consultant.

Preference is for local candidates.

Key Responsibilities:

Quality

·        Responsible for overall quality system compliance.

·        Ensure quality initiatives/goals and objectives align with business objectives.

·        Monitor the quality system for effectiveness.

·        Ensure the quality system is established, implemented, and maintained in compliance with all applicable regulations and standards.

·        Communicate, explain, and assure that all departmental duties and responsibilities are carried out in a way that is supportive and consistent with NeuroOne procedures, policies, and strategic plans.

·        Serve as the Management Representative.

·        Provide leadership and vision with a focus on prevention, continuous improvements, and customer satisfaction.

·        Manage internal and external quality system audits.

·        Mange Feedback and Customer Complaint System.

·        Oversee Material Review Board.

·        Manage final release process.

·        Serve as Corrective and Preventive Action (CAPA) Chair.

·        Manage risk through hazard analysis, FMEA and failure analysis.

·        Oversee training program and implement actives to enhance employee knowledge base regarding the quality system.

Regulatory

·        Develop and maintain infrastructure sufficient to support regulatory activities.

·        Manage regulatory strategies for securing marketing and clinical approvals.

·        Direct preparation of regulatory submissions and annual reports (as applicable) to regulatory bodies.

·        Maintain knowledge of existing and emerging regulations, standards, and guidance documents applicable to the business (including interpretation, communication of potential impact to the business, and assist in implementation of actions to assure compliance.

Required Skills and Experience:

·        Bachelor's degree in a science or engineering field required.

·        10 years of related experience in Quality Assurance in medical device industry.

·        Knowledge of FDA Quality System Regulations, ISO 13485, and Medical Device Regulation.

·        Demonstrated knowledge of U.S. and EU regulatory requirements and standards.

·        Strong communication skills and ability to manage/lead change.

·        Experience with product development, design verification, validation, risk management.

·        Prefer experience working with contract manufacturers and distribution partners.

Location:

·        Eden Prairie, MN