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.
- 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 appropriate Takeda 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
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to use that information to make scientifically sound Quality risk based recommendations and decisions.
- Accountable for compliance of commercial and clinical devices and combination products for global markets including timely completion of vigilance assessment activities, investigation and associated incident escalation and CAPA activities
- Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team member, share information and deliver results with a team
Decision-making and Autonomy
- Good analytical and problem solving skills
- Strong decision making skills
- Ability to influence others to deliver business results
- Strong time management skills and the ability to prioritize activities
- Accountable for analyzing product information, driving improvements in process as a result of product knowledge.
- Coordinate activities with SMEs across multiple time zones
- Escalation of potential device vigilance issues to direct management
- Assessing QA Compliance of internal quality system and associated records
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s Degree in BS in Engineering or equivalent technical discipline required, and at least 3 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with a minimum of 2 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, E.U. Medical Device and In-Vitro Diagnostic Directive (MDD & IVDD).
- 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;
- Advanced Degree; Experience working in a regulatory compliance function preferred.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.