Director, Regulatory Affairs Operations

Job Summary

This position is responsible for leading the development and optimization of regulatory operations, including regulatory processes, systems, submission planning, resource planning, regulatory intelligence, and metrics used to support global market access and ongoing compliance. Maintains current knowledge of global medical device regulations, acts as consultant to other departments, leads decision-making concerning policies, and participates in regulatory strategy. Defines information and actions needed to meet requirements, leads regulatory submissions required to obtain clearance or approval from governmental agencies. Interfaces with global regulatory affiliates and cross-functional partners to align regulatory deliverables, documentation, timelines, and implementation plans needed to achieve and maintain market access in global regions. Maintains compliance standing with regulatory and certifying agencies.

Job Details/Responsibilities

1.    In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 
2.    Provide expertise to global regulatory strategy development and implementation to achieve completed regulatory submissions in a timely and fiscally responsible manner.
3.    Establish and execute submission schedule(s) and achieve plan commitments. Assure tactical objectives are achieved in U.S. and non-U.S. submissions, label and advertising review, removals and corrections support as well as recommend and implement procedural improvements.
4.    Assure compliance requirements are achieved. Interface with U.S. and non-U.S. government officials on compliance issues that assures credibility bringing issues to successful resolution.
5.    Manage timely global regulatory clearances for new products; maintain existing marketing authorizations.
6.    Accountable for U.S. and non-U.S. submissions including but not limited to IDE, 510(k), technical files, establishment registration, and device listing.
7.    Lead and continuously improve global regulatory operations processes, tools, templates, submission planning practices, and documentation standards to support consistent execution across regions.
8.    Develop, monitor, and report regulatory operations metrics, including submission timelines, approval status, market access milestones, and compliance deliverables.
9.    Partners with Regulatory Affairs, Quality, Clinical, Product Development, Marketing, and global affiliates to align regulatory deliverables with business priorities and project timelines.
10.    Provide leadership for regulatory intelligence, impact assessments, and implementation planning related to changing global regulatory requirements.
11.    Oversee maintenance of regulatory documentation, historical records, submission files, and regulatory databases in accordance with applicable requirements and internal procedures.
12.    Utilizes the systems and processes in place to attract, develop, engage, train, and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
13.    Perform other duties as assigned.

Qualifications/ Background Experiences

Requires a four-year college degree and a minimum of twelve years of experience in Regulatory Affairs and/or Quality for medical devices or pharmaceuticals, including one or more of the following: clinical studies, global marketing applications, regulatory operations, or quality systems management. Of the twelve years of experience a minimum of five years must include supervisory experience. Basic computer software skills, i.e., Microsoft Office. Advanced degree or additional professional training preferred.