p/>If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find herea list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry) 5-7 years of experience requiredOur client is a leading Medical technology Industry and we are currently interviewing to fill this and other similar contract positions. Coursework, seminars, and/or other formal government and/or trade association training required Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel Good written and verbal communication skills and interpersonal relationship skills Good problem-solving, organizational, analytical and critical thinking skills Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices Solid knowledge and understanding of global regulatory requirements for new products or product changes.
See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. An established consulting firm in Torrance, serving a prestigious roster of international clients in the medical device and pharmaceutical sectors, are looking for a Regulatory Affairs Specialist who values precision, professionalism, and long-term career growth.
Whether it's glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ngersticks.
Irvine, California5 days ago
The Vice President of Quality Assurance will be responsible for the design, build, and implementation of the strategic framework of the Irvine Quality organization with a focus on driving effective and efficient business results, operational consistency, and cross-functional alignment. Change management –Champion innovation with the design and execution of changes in operating models as the Quality Unit scale up and develop strategies that impact the work of the Quality team.
li>Provide operational and strategic input into planning for expanded access programs and study specific documents such as synopses, protocols, ICFs, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plans, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc. Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Provide oversight of clinical affairs programs across all functional areas of the drug development process, including post-trial access programs coordinating the continued provision of investigational product to participants, in accordance with regional regulations.
Continuously monitor subject, similar and equivalent devices, alternative clinical techniques and methods through: • Post-Market Clinical Follow-up activities which serve to collect and evaluate long-term safety and performance • EMBASE congress and literature publications • Maintaining and growing clinical knowledge of competitive devices including alternative treatment methods • Develop Clinical Strategy and Scientific Methods • Develop strategies for preparing and submitting new products in global markets while maintaining existing products • Working with leadership and Regulatory Affairs develop strategies for preparing and submitting new and existing product plans and reports • Establish and approve scientific methods for clinical literature search protocols, data collection • Improve and Expand Clinical Communication • Communicate clinical information to cross-functional departments (project team) and stakeholders (KOL) while ensuring it's interpreted correctly • Provide guidance to development teams on clinical requirements for design, development, and marketing • Collaborates with NPD team to develop validation, testing plans, and protocols as required. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.