Manager, Regulatory Affairs

Company: TERUMO BCT, INC
Location: Lakewood
Posted on: November 8, 2024

Job Description:

Manager, Regulatory AffairsDate: Sep 24, 2024Location: Lakewood, CO, US Requisition ID: - 32768 At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.We are seeking an experienced Regulatory Affairs Manager to lead our efforts in managing and overseeing regulatory submissions and product registrations across medical devices, pharmaceuticals, and biologics. This key role involves ensuring compliance with global regulatory standards, supporting new product launches, and collaborating with cross-functional teams to prepare and submit documentation to health authorities. The ideal candidate will have a strong background in regulatory affairs, a thorough understanding of regulatory guidelines, and proven success in managing product registrations and submissions in a dynamic, fast-paced environment.ESSENTIAL DUTIES

• Provide direction, leadership and coaching to RA Associates to meet schedules and resolve technical or operational problems.
• Lead the development of strategic input and provide technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations.
• Manage Associates to develop regulatory strategies.
• Responsible for preparation or review of regulatory submissions.
• Represent regulatory on teams to develop regulatory strategies, including reviewing and influencing the various specifications and testing plans/reports.
• Manage multiple projects and prioritize tasks on a day-to-day basis to meet project schedules.
• Identify the need for new or modified regulatory procedures, SOPs, and lead in their development and implementation.
• Maintain current and grow regulatory knowledge of domestic and international regulations, guidelines, and standards.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
• Communicate regulatory strategy effectively to applicable departments, senior management, regulators, and regulatory agencies to achieve timelines.
• Review advertising and promotional materials for compliance with global regulations.
• Act as an effective regulatory consultant to management and other functions.
• Act as a leader who embodies regulatory expertise as well as business acumen.MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor's degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience 8 years experience in Regulatory Affairs and 1 year of direct or indirect management experience preferred.
  • Direct experience in gaining FDA or Notified Body approvals for devices or drugs or biologics.
  • Experience in an environment requiring negotiation, listening, persuasion, collaboration, compromise and analytic based judgement.Skills
    • Excellent written and verbal communication skills.
    • Self-motivated and able to work independently.
    • Ability to prioritize and handle several projects concurrently.
    • Leadership and mentoring skills.
    • Ability to maintain confidentiality in dealing with regulatory and clinical documentation.
    • Experience authoring a regulatory submission in the US, EU and/or Canada.
    • In-depth knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations.
    • Ability to apply business insight and understand how product approval strategy interacts with business strategy.
    • Demonstrated ability to collaborate and think innovatively.
    • Able to manage ambiguity.
    • Detail oriented, well organized and able to work both independently and in teams.Certificates, Licenses, Registrations Regulatory Affairs Certification (RAC) preferred.LOCATIONLakewood, Colorado - Open to candidates willing to relocate to the area.TRAVELSome travel may be required (5-10%).PHYSICAL REQUIREMENTS
      • Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
      • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.Target Pay Range: $125,900.00 -to -$157,400.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.Target Bonus on Base: 15.0%At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.We are proud to be an Equal Opportunity Affirmative Action Employer.Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces and maintain a drug-free workplace.
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Keywords: TERUMO BCT, INC, Commerce City , Manager, Regulatory Affairs, Executive , Lakewood, Colorado