Valeant Pharmaceuticals

Senior Director, Regulatory Affairs-Device

US-NJ-Bridgewater
Job ID
7851
Pos. Category
R&D
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

The Surgical Regulatory Affairs Director is responsible for regulatory development of surgical devices. The Director Regulatory Affairs will provide leadership and expertise to develop and execute regulatory submission strategies and policies for the product portfolio for the US

 

Responsibilities

Responsibilities may include but are not limited to:

  • Oversee the development of product regulatory strategies

  • Develop appropriate SOPs, processes and procedures to ensure compliance with regulations

  • Provides directional guidance to the business on how to prepare products for approval

  • Review and provide input on departmental policies and procedures

  • Oversee the preparation of  U.S. submissions

  • Ability to read, analyze and interpret associated regulations

  •  Manage assigned personnel
  •  Other job responsibilities as needed.

 

 

Supervise direct reports:  Yes

 

Scope of Position:  Support all North America – Surgical sites.

 

Key Relationships:

  • Maintain communications with internal stakeholders
  • Manage interactions with various regulatory authorities
  • Provide regulatory support to other Bausch & Lomb functions

Qualifications

Technical Competencies:

  • Knowledge of FDA class II & class III and device regulations and guidance
  • Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices
  • Ability to influence and partner with cross-functional teams in a global surgical organization
  • Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
  • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
  • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks

Professional Competencies:

  • Demonstrated ability in analytical reasoning and critical thinking skills
  • Strong capability to contribute and lead a team environment
  • Excellent communication skills; both oral and written\
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Demonstrated ability to contribute to a continuous learning and process improvement environment
  • Capacity to react quickly and decisively in unexpected situations
  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
  • Focused ability to influence operational excellence and performance metrics
  • Risk adverse where needed with the ability to identify potential solutions to complex problems

Experience:

 

  • 15+ years relevant medical device industry and regulatory experience; 10 + years in Class II and III devices
  • Ophthalmic device regulatory experience, a plus
  • Must demonstrate mastery in the following core competencies: influence key stake holders, business acumen, project management, relationship building, regulatory expertise
  • Bachelor’s degree in science or health related field; advanced degree a plus (PhD, MD, MS, PharmD, or equivalent)
  • Director level title is commensurate with previous experience and title.  May also hire at the Manager or Sr. Manager level

Be Aware of Recruiting Fraud

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

 

 

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