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Sr. Manager of Regulatory Affairs

Bothell, WA 98011

Posted: 01/09/2019 Employment Type: Direct Hire Industry: Software Job Number: 19282

Position Title:  Sr. Manager of Regulatory Affairs

Position Description:  Protingent Staffing has an exciting direct hire opportunity with our client in Bothell, Washington.

Job Requirements:
  • Responsible for developing a global product regulatory strategy
  • Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development
  • Develop a product regulatory timeline aligned to product development, with key regulatory milestone, and activities for agency filing
  • Coordinate with the team on the development of product labels
  • Ensure labeling content and product documentation is developed 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
  • Coordinate with key partners and regional counterparts to ensure timely and accurate submissions to Regulatory Authorities
  • Act as a regulatory contact for assigned country Regulatory Authorities 
  • Liaise with country-specific Regulatory Affairs personnel for international submissions and registrations
  • Manage interactions with other (e.g., Quality, Compliance) during Regulatory Authority inspections
  • Provide regulatory guidance/input to  device change control and internal product review boards
  • Manage assigned personnel
  • Other job responsibilities as needed.

Job Qualifications:
  • Knowledge of 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
  • 10+ years relevant medical device industry and regulatory experience
  • Aesthetic device regulatory experience highly preferred
  • Bachelor’ s degree in science or health related field

About Protingent:  Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.

Gazelle Medina
Sr. Technical Recruiter

I have been a Technical recruiter for over 20 years, much of that time with Protingent.  My passion is teaching people how to manage their career and effectively look for work.  I will keep working with a candidate until we find that right fit. I want to know what your dream job would be so I can help you find it.

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