Valeant Pharmaceuticals

Sr. Manager, Regulatory Affairs-Surgical Device

US-NJ-Bridgewater
Job ID
4962
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 Sr Manager is responsible for regulatory development of surgical devices. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities.

 

Responsibilities

Responsibilities may include but are not limited to:

  • Responsible for developing product regulatory strategy for surgical devices
  • Develop a product regulatory timeline aligned to the company’s product development, with key regulatory milestones, and activities for agency filing
  • Coordinate with the team on the development of product labels in accordance with regulatory requirements
  • Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
  • Manage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections
  • Provide regulatory guidance/input to surgical device change control and internal product review boards
  • Manage assigned personnel
  • Other job responsibilities as needed.

 

 

Supervise direct reports:  Yes

 

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

 

Key Relationships:

  • Internal Customers/Business Partners:
  • Quality Assurance
  • Research and Development
  • Manufacturing
  • Global Product Surveillance and Safety
  • Commercial Teams
  • Medical and Clinical Affairs
  •  External Customers/Business Partners:
  •  Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
  • MDs/ODs

 

 

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:

 

  • 10+ years relevant medical device industry and regulatory experience; 5 + years in Class II and III devices
  • Ophthalmic device regulatory experience, a plus
  • Bachelor’s degree in science or health related field; advanced degree a plus (PhD, MD, MS, PharmD, or equivalent)

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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