Autoimmunity Manager/ Sr. Manager, Regulatory Affairs- Medical Device IVD Experience

Overview

Job Summary

Autoimmunity Managers are responsible for planning and managing the operations of their assigned department to ensure successful operations in compliance with Quality Systems and other Regulatory, Human Resources, and Legal requirements, as well as all company policies. Responsible for ensuring department goals are met and budgets are managed. Responsible for implementing and improving processes, procedures and policies that enable and encourage optimum performance of the people and resources within assigned area. Responsible for managing and leading the work of direct and indirect reports, both individual contributors and people managers. Activities are performed in accordance with standard operating procedures (SOPs), Quality Management Systems regulations, Human Resources, Environment, Health and Safety, and other company policies. As a member of the Werfen management team is responsible for role modeling Werfen Values and Role of the Manager competencies and expectations.

Within the Regulatory Affairs Team, the Regulatory Affairs Manager will be responsible for the following, under the direction of Department Leadership. Responsible for managing a team of technical staff to develop regulatory plans for products, to prepare regulatory submissions such as 510(k), EU IVDR Technical Documentation, etc, to manage communications with Regulatory Agencies e.g. FDA, EU Notified Bodies, Health Canada, etc., For on-market products, the Regulatory Affairs Manager will oversee and assist in conducting regulatory market authorization impact assessments for product changes and associated regulatory submissions in the regions where products are marketed. The Regulatory Affairs Manager will oversee, and assist in the review of promotional materials to comply with regional regulatory requirements concerning advertising and promotion. The Regulatory Affairs Manager will champion continuous improvement efforts and lead department initiatives. This role will also be responsible for managing the regulatory intelligence program in collaboration with internal and external stakeholders and supporting initiatives for global regulatory compliance for Werfen invitro diagnostic (IVD) products.

Responsibilities

Key Accountabilities

• Teamwork: Coordinate with department leadership and other cross-functional areas including R&D, Project Management, Marketing, Quality Engineering, Manufacturing, and Quality Assurance to establish priorities and goals for design and development projects, product changes, international product registrations, review of Advertising & Promotional Materials, etc. Model effective team collaboration behavior.
• New Product Development Support: In collaboration with Department Leadership, assist the Regulatory Affairs team in developing regulatory plans and oversee implementation for introducing new products in various geographies, including but not limited to the United States, European Union, Canada, Australia, Japan, China, etc. Partner with regional partners globally as needed to ensure product development plans are comprehensive in addressing global regulatory requirements and supporting global regulatory approvals. Oversee and assist the Regulatory Affairs team in preparing and submitting regulatory submissions, including 510(k)s, Pre-submissions, IVDR Technical Documentation, etc. for new product development projects. Oversee and manage communications with Regulatory Agencies during product development and during the review of regulatory submissions. Ensure product development plans, analytical and clinical studies are aligned with Regulatory Agency expectations necessary for obtaining regulatory market approvals. Partner with Regulatory Affairs staff and cross-functional management to manage expectations and ensure overall smooth execution of regulatory strategies and plans in new product development projects. Ensure timely preparation of regulatory submissions through effective coordination of activities across Regulatory Affairs staff and cross-functional teams. Ensure regulatory submissions and associated communications with Regulatory Agencies are appropriately maintained in the internal document repositories.
• On-Market Support (Sustaining): Provide leadership, guidance and assistance to the Regulatory Affairs team in the regulatory impact assessments of changes on existing Market Authorizations that include but are not limited to design changes, changes to product composition, manufacturing processes, and the labeling of products. Oversee and assist in completion of regulatory submissions necessary for product changes. Review and approve product labeling, scientific papers, customer and public communications, advertising, and promotional materials to ensure compliance with regulatory requirements concerning advertising and promotion.
• Regulatory Intelligence: