Associate Director, Medical Device Safety Specialist

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Medical Device Safety Specialist in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

OBJECTIVES:

The Medical Device Safety Specialist (Associate Director) Medical Device Safety (MDS) Center of Excellence is a remote position reporting to the Head of MDS.

The position will support activities aimed at maintaining oversight over the safety of Takeda medical devices; be they as stand-alone or in combination with other Takeda products all through their lifecycle. These activities included but are not limited to ensuring Takeda meets mandatory safety reporting requirements for devices, support for post-market surveillance and risk management processes aimed at maintaining the safety and performance of Takeda devices. The incumbent will work closely with colleagues in Medical Safety, LOCs, Global Clinical Development, Global Regulatory Affairs, Device Quality, PV Compliance etc.

ACCOUNTABILITIES:

• Ensure organizational compliance with relevant medical device legislations and regulations
• Prepare, review, and approve regulatory compliance documents for internal and external audiences and regulatory authorities
• Develop and implement compliance programs and operational plans
• Lead functional teams or projects, providing guidance in complex situations and communicate progress/results to leadership teams
• Monitor and interpret relevant global and local medical device regulatory developments, assessing their impact on business operations.
• Work closely with the Head of MDS and other Device Safety Specialists to ensure the CoE deliverables are met.
• Be the liaison and subject matter expert for MDS in engagements with both internal and external stakeholders, including the Medical Safety, Device Quality Assurance, and Regulatory Affairs, Notified Bodies and Health Authorities.
• Uses initiative to identify and work towards improving processes geared at achieving compliance with global and local device regulations on an ongoing basis.
• Understand the fundamentals of device safety and should be able to work with case processing/product complaint handling teams to resolve inconsistencies or inaccuracies in device complaint evaluation.
• Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion
• Leverage well developed interpersonal skills to build and maintain positive working relationships with cross-functional groups throughout the organization.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Education & Experience

• Minimum: Bachelor’s Degree (or equivalent combination/training and experience) in a health-related discipline, preferably Nursing, or Biomedical Engineering.
• Minimum of 5 years’ experience in device safety or device quality assurance roles in the pharmaceutical industry or CRO. Project Management experience is a plus.
• Proficiency with office tools Windows, Excel, Power Point, Teams. Previous experience with safety/quality databases e.g. Argus and/or Trackwise is a plus.
• Subject matter expertise in clinical trials, capable of leading innovative research projects and mentoring teams.
• Understanding of the elements of risk management, device risk analysis; identification, estimation and mitigation.
• Proficiency in MedDRA language, providing leadership and strategic initiatives for medical product safety documentation.
• Ability to influence, supervise and coach others and able to develop strategic initiatives to achieve organizational goals.
• Experience and/or working knowledge of the key compliance requirements of the EU Medical Device Regulation and the FDA Code of Federal Regulations for devices and other global device vigilance regulations/standards e.g. ICH guidelines
• Highly detail oriented, critical thinking, self-driven, sound independent judgment and problem-solving orientation.
• Superior written and verbal communication skills with the ability to facilitate and lead cross-functional teams/projects. Demonstrated ability to manage complex network of relationships. 

This position is currently classified as “ remote” in accordance with Takeda’s Hybrid and Remote Work policy.

Empowering Our People to Shine

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No Phone Calls or Recruiters Please.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$153,600.00 - $241,340.00

EEO Statement

Takeda 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.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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