Bausch Health is a diverse 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 handles all regulatory development aspects of surgical devices and equipment. 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.
Supervise direct reports: Yes
Scope of Position: Support all North America – Surgical sites.
The ability to author and submit IDE, PMA and Class III submissions is needed in this role
Bausch Health is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
• Knowledge of medical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations
• Knowledge of domestic and international laws, regulations, and guidance that affect assigned devices
• Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
• 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
• Demonstrated ability in analytical reasoning and critical thinking skills
• Strong capability to contribute and lead a team environment
• Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
• 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
• 4+ years relevant medical device industry and regulatory experience
• Surgical device regulatory experience highly preferred in global environment
• Bachelor’s degree in science or health related field
• Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)
Bausch Health is an EEO/AA employer M/F/D/V.
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