Strategist, Manager Global Regulatory Affairs (Devices)

Company: Biolife Plasma Services
Location: Evanston
Posted on: September 21, 2023

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:Plasma-derived therapies are critical, life-saving medicines, which patients with rare and complex diseases around the world rely on every day. Global demand for these therapies, particularly immunoglobulins, has increased dramatically over the last 15 years, and continues to grow. Takeda is established as second largest provider of plasma-derived therapies (PDT) globally. Leveraging on 75+ year pioneering legacy, Takeda believes there is tremendous potential to do more to meet expectations of patients and health care providers with plasma-derived therapies for patients with immunologic, hematologic, autoimmune and other complex diseases.The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. -Takeda believes there is tremendous potential to do more to meet patients' and health care providers' expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. -You will develop and execute regulatory strategies for medical devices and device components within the PDT BU and you will report to the Team Lead, Global Regulatory Affairs Device for the business unit. You can be based in our Bannockburn, IL office, Cambridge, MA office or be fully remote.How you will contribute:

• Provide regulatory device strategies for Medical Device Software (SaMD/SiMD) and stand-alone devices, and Blood Establishment Computer Software (BECS)
• Apply knowledge of the regulatory environment, including current regulations and guidance, to develop Regulatory strategies for SaMD/SiMD that are aligned with R&D and company goals -
• Provide strategic regulatory guidance for changes to existing devices to the teams within the PDT BU organization
• Be an internal consultant for the R&D team to facilitate indication changes, market expansions, and integrations of the software between applications or in new use environments.
• Manage contingency planning and identify more efficient ways to accomplish tasks.
• Guide others in defining and prioritizing key decision criteria when making business-level decisions.Minimum Requirements/Qualifications:
  • BS required
  • Minimum 5 years of experience in the pharmaceutical/biotechnology industry or working at government health authorities
  • 4 years in a Regulatory Affairs Device role
  • Experience with SaMD or SiMDWhat Takeda can offer you:
    • Comprehensive Healthcare: Medical, Dental, and Vision
    • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
    • Health & Wellness programs including onsite flu shots and health screenings
    • Generous time off for vacation and the option to purchase additional vacation days
    • Community Outreach Programs and company match of charitable contributions
    • Family Planning Support
    • Flexible Ways of Working
    • Tuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.Base Salary Range: $105,000 Range Min to $150,000 Range Mid, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsUSA - IL - BannockburnCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Biolife Plasma Services, Evanston , Strategist, Manager Global Regulatory Affairs (Devices), Executive , Evanston, Illinois