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
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