Associate Director, Medical Device Safety Specialist

Initial Therapeutics, Inc.; United States; Remote; USD 153,000 - 242,000; Full time

Job summary

Join a forward-thinking company as an Associate Director, Medical Device Safety Specialist, where you'll play a crucial role in ensuring the safety and compliance of medical devices. This remote position offers the chance to lead initiatives that impact patient health and drive innovation in the pharmaceutical industry. Collaborate with cross-functional teams and leverage your expertise in device safety and regulatory compliance to make a meaningful difference. With a commitment to empowering employees and fostering a collaborative environment, this role provides an exciting opportunity to contribute to life-changing work while enjoying a range of benefits and a competitive salary.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Tuition Reimbursement

Paid Volunteer Time Off

Sick Leave

Paid Vacation

Well-being Benefits

Qualifications

• Bachelor's degree in health-related field required; 5+ years in device safety preferred.
• Experience with project management and regulatory compliance is essential.

Responsibilities

• Ensure compliance with medical device regulations and prepare regulatory documents.
• Lead projects and teams to achieve compliance and monitor regulatory developments.

Skills

Device Safety

Regulatory Compliance

Project Management

Risk Management

Communication Skills

Critical Thinking

Education

Bachelor’s Degree in Health-related Discipline

5+ Years in Device Safety or Quality Assurance

Tools

Microsoft Office Suite

Argus

Trackwise

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 Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 include 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.
• Use 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 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 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

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

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

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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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