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Manager - Regulatory Affairs

Company: Merz North America, Inc.
Location: Raleigh
Posted on: February 22, 2021

Job Description:

The Manager, Regulatory Affairs develops and executes regulatory strategies for new products and lifecycle management of existing products. Acts as primary contact for regulatory on cross functional product development and post-marketing teams and leads submission activities throughout product development and lifecycle. RESPONSIBILITIES Regulatory Support for Project/Product Teams

  • Provide regulatory strategic direction on projects/products.
  • Identify and assess regulatory risks and project/product issues as well as recommend solutions and strategies to teams and management.
  • Conduct and analyze regulatory research providing guidance to teams on past precedence, competitive landscape, and recommended regulatory pathways.
  • Effectively manage project timelines as defined by department, project team, and corporate objectives.
  • Provide guidance and participate on execution of Product Development Design Control Activities
  • Provide guidance and participate on Risk Management Activities
  • Provide guidance on clinical studies Regulatory Submissions
    • Lead major submission activities.
    • Plan and prepare regulatory submissions medical device or combination products for new and existing products to ensure the timely approval for clinical and non-clinical studies and marketing applications.
    • Ensure documents are in compliance with current regulations and guidance. --Sustaining Regulatory Support
      • Maintenance of establishment registrations and listings
      • Maintenance of Unique Device Identifier(s)
      • Provide regulatory input to Quality and Operations functions for post-market project activity, including change control assessments Labeling--
        • Work with Commercial and R&D colleagues to develop 'best in class' labeling.
        • Review product labeling for regulatory compliance Communication with Regulatory Authorities
          • Primary point of contact for Global Health Authorities. Communicate regulatory requirements to internal stakeholders.
          • Interact with contract manufacturers, affiliates and distributors.
          • Maintain current regulatory knowledge of regulations, guidelines, and standards and apply appropriate implementation strategies.-- Management
            • Mentor and provide guidance to junior staff. May manage and supervise direct reports including work assignments and performance feedback, appraisals and reviews. Further Tasks Provide support to other regulatory staff as needed and perform duties and assignments as required. Communicate and raise questions/issues to the attention of regulatory management. Additional duties as needed to support the business and overall company objectives. REQUIREMENTS
              • BA/BS in scientific or health discipline
              • Minimum 5 years relevant regulatory experience
              • Direct experience with development, preparation and submission of IDE, Original PMA, PMA Supplements (30DN, Real Time Supplements, 180-DS)
              • Direct experience in FDA Establishment Registrations and Device Listings
              • Strong knowledge of US Medical Device (Class I, II, III) regulatory environment and FDA regulations and guidance. Class III Medical Device Experience Preferred.
              • Proficient in all MS Office applications
              • Proficient in Adobe DC or Adobe Professional applications
              • Proficient in FDA eSubmitter applications
              • Demonstrated organizational skills, ability to independently prioritize work and detail oriented
              • Strong verbal and written communication skills
              • Good working knowledge of Medical Device/Combination Product FDA regulations
              • Hands-on Experience with preparation of Regulatory Strategy Assessments
              • Hands-on Experience with preparation of 510(k), IDE, Original PMA including preparation of electronic submissions
              • Experience with regulatory/compliance in clinical, non-clinical, manufacturing issues
              • Demonstrated leadership skills and experience as a team lead is preferred
              • Excellent interpersonal skills Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Merz North America, Inc., Raleigh , Manager - Regulatory Affairs, Executive , Raleigh, North Carolina

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