Senior RA Principal

Job Description Summary

Job Description

Position Summary:

The Sr. Regulatory Affairs (RA) Principal will provide technical regulatory expertise for multiple franchise(s), platform(s), or RA Program(s). The Sr. Principal provides regulatory guidance across a wide variety of product franchises and/or programs, including products from all facets of the business. The Sr. Principal will provide guidance and recommendations to Senior Leadership on challenging regulatory issues and act as a mentor to more junior members of the Regulatory Affairs team. They may be responsible for implementing new processes and procedures to ensure greater compliance and/or process efficiencies, as well as implementing policies related to departmental or business goals. The Sr. Principal will generate, and provide guidance related to generation of, complex regulatory strategies. The Sr. Principal must be knowledgeable about current and possible future policies, practices, trends, technology, and information affecting the business and organization.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

• Serves as subject matter expert on corporate initiatives in support of executive leadership team initiatives.
• Interprets regulations and standards for RA and critical RA resource groups (e.g., Clinical, R&D, Manufacturing, Quality).
• Critically assesses impact of studies and data on project outcomes.
• Provides cross-platform support and training as needed.

• Participates in Steering Committees as needed.
• Establishes relevant systems and procedures within regulatory to implement applicable quality system requirements. Creates and manages QMS policies, structure and strategy to support key programs.
• Understands all aspects and phases of the submission process from discovery through post launch and maintenance.
• Leads new ideas/requirements and gains stakeholder feedback during the process, and ensures new ideas align to strategic roadmaps.
• Influences and interprets guidance documents.

• Responsible for the development and leadership of long-term department goals.
• Understands global requirements and monitors changes to understand impact to business.
• Understands global regulatory requirements and develops different regulatory pathways and communicates options to cross functional teams.
• Partners proactively in the product development process, as needed, to provide strategic guidance for development planning from the exploratory phases for new products through the ongoing compliance phases for commercialized products.
• Communicates and trains team members on internal Regulatory Affairs procedures and policies.

• Provides input and decision making into key business decisions and resource planning.
• Represents RA in due diligence and participates in product acquisition teams.
• Participates in Design Reviews for a variety of product types.
• Represents BD in external working groups.
• Builds relationships with key advocates, regulators, and internal/ external stakeholders to ensure that BD point of view is understood and carried forward.

Required Qualifications:

• Comprehensive knowledge of United States, European, and/or international regulations and standards covering medical devices.
• Experience in continuous improvement projects, project management, product development processes, and design control.
• Strong knowledge of design control elements, QMS processes, and Regulatory processes.

• Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently.
• Successful track record of global approvals.
• Effectively copes with change and can comfortably handle risk and uncertainty.

Preferred Qualifications:

• Makes timely and effective decisions, balancing the need for more information or analysis with the need to be decisive.
• Ability to be effective in complex projects with ambiguity and/or rapid change.
• Ability to interpret medical device testing methods and statistics, as applicable.
• Excellent written and verbal communication skills including ability to communicate across culture, work with others in team environment, and demonstrate effective interactions with technical personnel (scientific and legal).
• Knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization.

• Demonstrated self-starter, and highly motivated.
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
• Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results.
• Advance degree preferred.
• RAC certification.

• Experience with Clinical Trial applications (US IDE) and US Class III devices.
• Medical device experience in Oncology, ESKD and/or PAD.

Education and/or Experience:

• Bachelor's degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a minimum of ten years of experience, or equivalent combination of related education and experience.
• Preferred minimum of ten-to-fifteen years of experience in the medical device industry, with at least ten years in a regulatory role.

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift