Senior Manager

Job Description

Description

The Sr Manager Regulatory Affairs represents US regulatory affairs for device development projects. Responsible for development, communication, and execution of US regulatory strategic plans to Global Regulatory Lead (GRL) and project team. Plans and prepares (or oversees) complex regulatory submission documents primarily for US regulatory filings, ensures technical accuracy, and regulatory compliance. Ensures that applications are executed appropriately and submitted on time.

Directs communication and interactions with FDA, as primary contact for the related projects. Utilizing detailed, in-depth understanding of regulations for device products, leads, and participates in global regulatory product teams, interprets regulations, and provides regulatory guidance. Supports management with implementation of departmental strategies and policies.

Duties and Responsibilities:

Represents US Regulatory in project teams. Develops US regulatory filing strategy, with minimal supervision. Provides regulatory strategy and guidance to global product owner/project team in line with commercial objectives.

Works collaboratively with GRL/regulatory/cross functional team to resolve complex project issues.

Utilize US device regulatory expertise and extensive knowledge of requirements to strategically interpret, plan, and communicate with the team.

Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.

Ensures planned device development activities comply with US regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.

Plans and prepares (or oversees) complex regulatory documents for US (PMA, IDE, IDE supplements and annual reports, FDA meetings) and potentially OUS submissions, under minimal supervision.

Prepares clear, complete, and accurate documents that are logically constructed and comprehensive in content and on time.

Reviews labeling and packaging components for new products/indication extensions to ensure accuracy and compliance with regulations and aligned with the commercial needs.

Communicates planned/approved changes with operations, commercial, medical affairs, and marketing.

Effectively plan, organize, and conduct formal meetings with regulatory agencies. Be able to negotiate to ensure acceptance of appropriate regulatory strategy. Assures compliance with project team timelines and milestones.

Maintains professional relationships with functional areas outside regulatory.

Develops professional relationships with Health Authorities through supervised process.

Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities.

Assists in training and mentoring of personnel, performs peer review of documents, and may supervise as appropriate.

Fosters a dynamic working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging intra- and inter-departmental team members to meet and/or exceed expectations.