Global Regulatory Affairs Expert
7 days ago
We are seeking a highly skilled Global Regulatory Affairs Expert to join our team. In this role, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint.
Key Responsibilities:- Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
- Problem solve and escalate regulatory and compliance issues to senior management as necessary
- Drive continuous improvement in internal processes and customer satisfaction
- Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW
- Support that QMS requirements are followed and executed consistently from RA perspective
- Support efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content
- Support regulatory impact assessments for change controls and other RA/QA items from a review and approve level
- Assist in preparing, auditing, editing, and publishing registration documentation as needed
- Support business export control (BEC) listing of product for release globally per RA requirements
- Minimum bachelor's degree in RA, QA, engineering, or other science-related discipline
- Advanced degree (e.g. MS, Life Sciences) preferred
- RAPS RAC certification preferred
- Minimum of 5 years of strong Regulatory Affairs/Compliance experience in medical devices
- Knowledge of global Regulatory Affairs requirements, regulations, and standards
- Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect talented professionals like you with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Our platform offers a wide range of job openings, from entry-level positions to experienced roles.
We believe in providing our associates with a valuable, competitive package of compensation and benefits programs. Our salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. The salary offered to a successful candidate is based on experience, education, skills, and actual work location.
The estimated salary for this position is $121,100.00 - $199,800.00 USD Annual, depending on the location and qualifications of the candidate. If you're interested in this opportunity, please visit our website for more details and to apply.
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