Job Title: Device Quality Compliance Lead
Location: Lexington, MA
About the role:
Device Quality Compliance Lead is an experienced Quality and Technical professional who supports the overall device and combination product quality strategy to maximize the benefit and sustainability of Takeda’s in-line products and to bring Takeda’s pipeline products to a sustainable existence on the market.
- Maintain compliance of Takeda Global Quality Device and Combination Products (DCP) processes and quality records against changing device and IVD regulations particularly the EU MDR, IVDR, MDSAP
- Responsible for certification and product licensing. Responsible for tracking of licensing information and ensuring site commitments for post-licensing approvals and updates are completed on-time.
- Oversight on Regulatory Labeling for DCP products
- Technical and/or Medical Device file oversight as required per appropriate regulations
- Support maintenance of product compliance to CE marking requirements.
- Responsible for MDR and vigilance reporting and field action execution according to applicable regulations and internal procedures.
- Provide regulatory intelligence analysis with impact to processes and/or products
How you will contribute:
- Drives quality improvement initiatives
- Coordinates and supports all management reviews, DHF audits and independent design reviews as required
- Regulatory Intelligence oversight for all global DCP regulations for clinical and on-market changes
- Internal and external audit support including site readiness.
- Accountable for tracking global Device and Combination Products licensing/certifications/registrations information and ensuring all appropriateTakeda commitments are implemented and in compliance
- Maintain compliance of Takeda Global Quality Standards, Device Quality Manuals, Quality Statement and Quality Policy
- Principal to deliver support training program in relation to requirements
What you bring to Takeda:
- Bachelor’s Degree in BS in Engineering or equivalent technical discipline required, and at least 5 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with a minimum of 3 years Quality Assurance and/or Quality Compliance roles;
- Good understanding of EU, US and international medical device and combination products regulations and standards including but not limited to Part 4, CFR 820, 803, ISO 13485, MDSAP, ISO 14971.
- Full understanding of Medical Device Regulations (MDR) and In-Vitro Diagnostics (IVDR) Regulations
- Experience with Class I & II & III sterile and non-sterile medical devices
- Experience with Implantable Devices and Diagnostics
- Experience with clinical development and regulatory filings
- Experience through interacting and collaborating with cross-functional global teams; project/program management and operational excellence preferred;
Desired: Advanced Degree; Experience working in a regulatory compliance function preferred.
What 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
- Professional training and development opportunities
- Tuition reimbursement
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More 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 posting excludes Colorado applicants.
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.
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