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Senior Director, Regulatory Affairs, Advertising & Promotion

Company: Patelco Credit Union
Location: Minnetonka
Posted on: February 15, 2021

Job Description:

Senior Director, Regulatory Affairs, Advertising & Promotion Friday, February 5, 2021 As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, electrophysiologists and cardiothoracic surgeons around the globe count on AtriCure to deliver best-in-class solutions that can treat even the most complex cases. Our Isolator-- Synergy--- Ablation System is the first and only medical device approved by the FDA for the treatment of long standing persistent Afib, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, and we are expanding into pain management therapies. We invest in innovation, clinical science, and education to focus on improving lives for our patients' worldwide. POSITION SUMMARY: This position will responsible for leading AtriCure's advertising and promotion materials review process to ensure compliance with product registrations and regulatory requirements worldwide throughout the product life cycle.The Sr. Director will work collaboratively with Marketing, Scientific Affairs, Health Economics and Reimbursement, Legal/Compliance, Sales and International Distributors to develop and implement advertising and promotional labeling for AtriCure's product portfolio, applying (i) insight and sound judgment to make solid decisions on promotional programs, and (ii) expertise and organizational influence to develop promotional programs and tactics that align with applicable laws, regulations, and company policies, all while supporting the achievement of business objectives. ESSENTIAL FUNCTIONS OF THE POSITION:

  • Execute on advertisement/promotional policies and procedures for Commercial Materials distributed both internally within AtriCure as well as globally to external customers.
  • Ensure communications are truthful, non-misleading, accurate, and fairly balanced as well as supported by reliable, sound scientific data on file.
  • Maintain a deep and current awareness of evolving FDA, European and International regulations and interpretations, advisory comments, enforcement actions and policy issues affecting the medical device Industry.
  • Identify, interpret and communicate regulatory perspective on advertising and promotional activities and related risk to relevant stakeholders and management.
  • Partner with Marketing, Scientific Affairs, Health Economics and Reimbursement, Legal/Compliance, Sales, International Distributors and other departments as needed to ensure Commercial Materials are reviewed in a timely, consistent manner across AtriCure platform of products throughout the product life-cycle.
  • Ensure commercial communications and promotional claims are consistent and appropriate in view of product registrations, applicable laws, regulations, and policies and supporting by sufficient substantiating evidence on file.
  • Assess advertising and promotion-related processes and procedures to enhance efficiencies and recommend/implement policy and/or process changes as needed.
  • Monitor company website content for accuracy in accordance with an established review schedule.
  • Surveil competitor advertising to keep abreast of market promotional and advertising strategies and identify potentially violative competitive materials.
  • Interface with relevant regulatory authorities and notified bodies as needed.
  • Maintain associated advertising/promotion best practices documents, tools, procedures, and work instructions.
  • Own and maintain claims matrices for products for agency review and claims traceability.
  • Train employees to CMR (Commercial Material Review) policies during employee on-boarding and annual updates. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
    • Regular and predictable work performance
    • Ability to work under fast-paced conditions
    • Ability to make decisions and use good judgment
    • Ability to prioritize various duties and multitask as required
    • Ability to successfully work with others
    • Additional duties as assigned BASIC QUALIFICATIONS:
      • Bachelor's degree required or demonstrated equivalent combination of education, training and experience
      • 8 years of regulatory affairs experience in a medical device manufacturing environment, with experience executing and/or managing functional areas described above
      • Extensive knowledge of global medical device regulations and standards particularly related to labeling and promotion including but not limited to FDA, EU and International Requirements.
      • Demonstrated leadership with the ability to proactively identify and communicate risks and opportunities and the ability to effectively influence and implement change.
      • Ability to work in a fast-paced, technically challenging environment where drive is critical to success
      • Effective interpersonal and communication skills, diplomacy and ability to influence across business functions
      • Proficient computer skills; able to use standardized office software products, i.e., Microsoft Word, Excel, PowerPoint, etc.
      • Ability to travel 25% PREFERRED QUALIFICATIONS:
        • Regulatory Affairs Certification (RAC)
        • Previous experience with ablation, cardiac surgery and Left Atrial Appendage (LAA) closure devices OTHER REQUIREMENTS:
          • Ability to regularly walk, sit, or stand as needed
          • Ability to occasionally bend and push/pull as needed
          • Ability to pass pre-employment drug screen and background check AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 15 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, PetInsurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits AtriCure participates in the federal E-Verify program to confirm the identity of and employmentauthorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Keywords: Patelco Credit Union, Minnetonka , Senior Director, Regulatory Affairs, Advertising & Promotion, Executive , Minnetonka, Minnesota

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