Plans, organizes, teaches, and provides feedback to promote and direct student success. Responds to students in a timely manner. Communicates with students, departments, and university officials via university provided tools and resources.

Role Description Elvie has a need for a detail-oriented, passionate and dynamic individual with a desire to be an integral part of our growing Quality and Regulatory team. You respect rules and regulations but are not afraid to do things differently and challenge ‘business as usual’. You are able to understand and interpret global regulations to support the strategic placement of our growing portfolio of both medical and non-medical products into world-wide markets. Provide guidance to the cross-functional teams to successfully support and drive products to market, from R&D and Product Development, through to Sales and Marketing. You are organised and logical and can form a clear path through the noise when complex decisions need to be made. You are able to work autonomously and be the authoritative voice for Regulatory Affairs. You can develop plans of action and communicate them with confidence to all functions and levels within the business. You will have experience working within the Medical Device industry, in a global regulatory focused role. You are excited by the prospect of defining the regulatory strategy and best practices in a rapidly growing and exciting business. Experience with multi category product portfolios (consumer electronics, childcare products, cosmetics, etc) is highly desirable. Qualifications - A degree in a relevant engineering, design or science discipline (or equivalent qualification). - Extensive experience in medical device regulatory affairs including direct experience working with EU Notified Bodies, EU Authorised Representatives, MHRA, US FDA, FCC and Health Canada. - Experience in product placement in MDSAP countries would be an advantage. - Ability to interpret worldwide regulations to ensure uninterrupted supply of our products to our customers. - Experience ensuring a high level of compliance with MDR, ISO 13485, 21 CFR 820. - Must be familiar with commonly used productivity & statistical software such as Microsoft Office, Google suite and eQMS solutions. Requirements - Partner with cross functional teams to develop global regulatory requirements and timelines that align with the business expansion and new product launches. - Provide clear and unambiguous guidance on regulatory requirements for new market entry and design changes for medical devices, childcare products and consumer goods. - Lead regulatory submissions to support new product launches including the development and maintenance of FDA 510(k)’s, Technical Files and Essential Requirements Checklists. - Communicate with world-wide agencies, in-country representatives and regulatory bodies to support our products. - Understand new or changing regulatory landscapes that could impact our products. - Support the development and continual improvement of internal regulatory processes. Benefits - 9-day fortnight working pattern - for our full time employees we work 9 days every fortnight with every other Friday as a non-working day for you to spend as you wish. - Lots of flexibility: whether it’s working from home, doing the school run, or life admin. We believe trust and flexibility allows everyone to show up as their best selves. - 25 days’ annual leave, plus bank holidays. - Life leave days; getting married, moving house, menopause or just things that you can’t put a label on that matter to you. - 5=10 leave: 10 days’ additional leave on your 5th and 10th years of service. - Generous parental leave policies; maternity & adoption (16 weeks at full pay, then 8 weeks paid at 75% followed by 15 weeks at SMP rate), paternity/partner (6 weeks at full pay to take at any point during the first year of your child’s life), shared parental leave. - Healthcare plans, life insurance, and an employee assistance program for you and your family. - A tax-efficient group pension scheme. - Group income protection; protect your salary if you get sick. - Generous employee and friends & family discounts on Elvie products. - Wellbeing support from YuLife and access to SmartHealth app with unlimited GP appointments for you and your family.

Title: Clinical Dietitian WFH PRN Location: Nashville, TN United States, Job Description: Work Type: Remote, Full Time Job ID:4176383 Do you have the PRN career opportunities as a(an) Clinical Dietitian WFH PRN you want with your current employer? We have an exciting opportunity for you to join Work from Home which is part of the nations leading provider of healthcare services, HCA Healthcare. Job Summary and Qualifications To collaborate as a member of the interdisciplinary healthcare team to provide patients of all age groups and acuity levels with high quality Medical Nutrition Therapy following the Nutrition Care Process. Note: The following is not intended to be a finite list of responsibilities for this Clinical Dietitian position Performs timely nutrition screenings and assessments in accordance with the Corporate Screening and Assessment Policy Perform nutrition focused physical exams on patients who are at nutritional risk. Identify patients at nutritional risk based on established criteria Evaluate age specific, developmental and disease specific nutritional needs of patients Develop and implement individualized nutritional plan of care. Evaluate and monitor the effectiveness and outcomes of medical nutrition therapy interventions. Identify patient nutrition education needs and provide nutrition counseling to patients, family, and/or caregivers. Participate in the competency assessment process and achieve a passing score of 80% or higher on RD chart audits Adheres to nutrition care guidelines, the nutrition care manual, department/facility guidelines and/or protocols to provide evidence-based nutrition care. Integrates the Academy Code of Ethics in all areas of practice. What qualifications you will need: Bachelor's Degree in Nutrition, Dietetics, or equivalent required Completion of an ACEND-accredited supervised practice program required One to two years of hospital clinical nutrition experience preferred Licensure, Certifications, Training and Credentials: Registered Dietitian with the Commission on Dietetic Required Benefits Work from Home, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include some or all of the following: - Comprehensive benefits for medical, prescription drug, dental, vision, behavioral health and telemedicine services - Wellbeing support, including free counseling and referral services - Time away from work programs for paid time off, paid family leave, long- and short-term disability coverage and leaves of absence - Savings and retirement resources, including a 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service), Employee Stock Purchase Plan, flexible spending accounts, preferred banking partnerships, retirement readiness tools, rollover support and financial wellbeing counseling - Education support through tuition assistance, student loan assistance, certification support, dependent scholarships and a partnership with Galen College of Nursing - Additional benefits for fertility and family building, adoption assistance, life insurance, supplemental health protection plans, auto and home insurance, legal counseling, identity theft protection and consumer discounts Note: Eligibility for benefits may vary by location and position. For more than 100 years, Wesley Healthcare has provided exceptional care to thousands of families in Wichita and throughout Kansas and Northern Oklahoma. Wesley Medical Center is a member of the Wesley Healthcare network within Greater Wichita and has been an HCA Healthcare hospital since 1985. Our physicians treat more than 24,000 patients annually, making Wesley Medical Center the most preferred hospital in Kansas and northern Oklahoma. Additionally, our obstetricians and childbirth staff deliver more than 6,000 babies each year, more than any hospital in a 13-state region. Home to Wesley Childrens Hospital, the regions first and Wichitas only childrens hospital, we care for children in a unique space designed specially for kids and their families. And as a Level I Trauma Center and the only Level II Pediatric Trauma Center in Kansas, we are prepared to treat any medical emergency, any time of day. HCA Healthcare has been recognized as one of the World's Most Ethical Companies by the Ethisphere Institute more than ten times. In recent years, HCA Healthcare spent an estimated 3.7 billion in cost for the delivery of charitable care, uninsured discounts, and other uncompensated expenses.

Title: Principal Biostatistician Job Description: Job Location: US - Remote Job Overview: Provides all biostatistical services to meet the requirements of all Caidya clients, including full-service, Global Clinical Analytics (GCA), and other type studies. Job Duties and Responsibilities: A Principal Biostatistician is expected to be a very successful Senior Biostatistician who establishes excellence in one or more areas providing some unique leadership to Caidya. Examples of areas of excellence include but are not limited to: - Proven written and oral communications with regulatory agencies. - Special expertise in more complex statistical analytical methods not well known to all biostatisticians. - Established expertise in a medical therapeutic area. - Established a long-term high-level relationship with a Caidya sponsor. - Overall high-quality work and a strong reputation for statistical knowledge. - Exhibited leadership and organizational skills to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials. - Demonstrated ability to adapt and adjust to changing priorities and deal with uncertainty and risks. - May be given some supervisory responsibilities for junior staff or department areas. Supervisory Responsibilities: - No supervisory responsibilities. Job Requirements: Education - PhD or Master's in statistics or related area, or equivalent degree globally Experience - PhD + 7-10 years (or MS + 10 years) experience in pharmaceutical, CRO, or related environment. Skills/Competencies - Interpersonal and communication skills: Excellent written and oral communication skills including technical writing of all statistical results. - Ability to develop professional presentations for presenting statistical issues and solutions to clients internally. - Ability to effectively learn and handle new or unfamiliar statistical methods. - Ability to find needed written resources and interact with other Biostat staff with the needed familiarity. - Willingness to share expertise with junior staff members. Capabilities - Excellent broad ranging understanding of statistical methods and issues. Demonstrates leadership in several areas of statistics. - Has a developed expertise in 1-2 therapeutic areas. - Ensures statistical quality: Reviews and monitors quality of statistical tasks and project deliverables provided by statistical project team. - Deep working knowledge of clinical drug development process: In-depth understanding of phases of clinical trials and relevant statistical considerations that apply to Phase I-IV studies and non-inferiority concepts. - Has strong knowledge of GCP and ICH guidelines and other regulatory guidelines related to statistics. - Develops capability for interacting with regulatory agencies on behalf of sponsor matters. Such capability would include ability to write statistical reports and/or present oral arguments to such agencies. - Ability to serve as a Project Manager for GCA studies. Coordinate keeping tasks and project activities in line with agreed timelines and budget. - Excellent training and presentation skills: Has the ability to clearly communicate statistical concepts and successfully train and develop staff through coaching and presentations. - Strong understanding of departmental and company procedures which relate to tasks that are performed routinely: Strong understanding of all departmental SOPs and good understanding of all required company SOPs. - Familiarity with Caidya Functional Areas that Biostatistics interacts with on a regular basis (Proposals, Finance, Clinical Operations, Data Management, Medical Writing), and updates appropriate personnel regarding project scope changes which may impact their areas. - Support the Business Development process through RFP process, bid defenses, attendance at scientific meetings, etc. #LI-BG1 #LI-Remote