Senior Regulatory Affairs Specialist
2 weeks ago
Job Title:
Senior Regulatory Affairs Specialist
Duration:
9 months
Location:
Irvine, CA (Onsite)
Shift: 8 am to 5 pm.
Our Client is a
Global medical device Manufacturer.
We are looking for a
Senior Regulatory Affairs Specialist
to complete and maintain regulatory approvals and clearances of assigned products.
Create
regulatory submissions
(exercising judgment to protect proprietary information) for finalization and submission by
OUS
affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).
Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing the impact of proposed and current global regulations and proposing suggestions for expediting approvals.
Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on
regulatory requirements,
including presenting alternatives for meeting regulatory requirements resolving conflicts between those requirements and development issues, and/or reporting to management.
Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content. and guidance on process improvement projects, based on prior experience and responses from affiliates.
Other incidental duties assigned by Leadership.
Requirements:
Bachelor's Degree or equivalent in a scientific discipline (e.g., Biology, Microbiology, Chemistry)
3-5 years of
regulatory affairs
or related experience in a medical device, pharma, or a related industry. International regulatory affairs experience is desired
Excel spreadsheet
Design history files experience is desired.
Team player, strong communicator, and problem solver.
Experience with Ignite, LMS
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.
Solid knowledge of new product development systems
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
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control
-
Senior Regulatory Affairs Specialist
2 weeks ago
New York, United States ACE Partners Full timeOur customer is looking for a Senior Regulatory Affairs Specialist to join a team of 7 and supporting the product submissions, regulatory guidance, and registering products. Duties Include: Maintain and establish regulatory functions for medical device and environmental compliance. Uphold Quality Management System for domestic and international...
-
Senior Regulatory Affairs Specialist
2 weeks ago
New York, United States Laborie Full timeWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers...
-
Regulatory Affairs Specialist
2 weeks ago
New York, United States ACE Partners Full timeMy client are looking for a Regulatory Affairs Specialist with experience in Asia Pacific Product Registrations. You MUST be willing to work hybrid in office at Exton, Pennsylvania. Essential Duties and Responsibilities: Author and review China, South Korea, Japan and additional submissions as well as US and EU Submissions Work cross functionally with...
-
Regulatory Affairs Specialist
4 weeks ago
New Haven, United States CareerBuilder Full timeRegulatory Affairs Specialist Jobs (Found 1 Job) Nationwide and Remote jobs are not shown OverviewThe Regulatory Affairs Coordinator will integrate with the RA team and provide general support as needed under the guidance of RA colleagues. This is an exciting opportunity with potential for... #J-18808-Ljbffr
-
Regulatory Affairs
3 weeks ago
New York, United States iRiS Recruiting Solutions Full timeRegulatory Affairs Regulatory Affairs SME Compensation: $110,000 to $130,000 Location: Shelbyville, IN ABOUT OUR CLIENT: Our client is a leader in their space, in SE Indianapolis. Their state-of-the-art facility will be where groundbreaking ideas become reality. Their contracts unrelated to automotive will provide long term stability. As a leading player in...
-
Regulatory Affairs Specialist
2 weeks ago
New Freedom, United States Sterling Life Sciences Full timeJob Description One of our top clients is recruiting again! They are looking for a Regulatory Affairs Specialist for their facility. Interested job seekers should have work experience with a highly successful and well-established medical device manufacturer. An overview of the Regulatory Affairs Specialist's responsibilities: 1) Be responsible for...
-
Regulatory Affairs Specialist
1 week ago
New York, United States Cypress HCM Full time· 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry · Working knowledge of FDA, and CE marking requirements for IVD products is a plus · Able to work independently and with others · Able to work with minimal supervision · Excellent computer applications skills ·...
-
VP of Regulatory Affairs
1 week ago
New York, United States Leaman Life Sciences Full timeVP of Regulatory AffairsI am partnered with a scientifically driven late-stage, well funded biopharmaceutical company who are looking to build out their Solid Tumors pipeline. They are looking for a Vice President of Clinical Regulatory Affairs to be responsible for the development and execution of the company regulatory strategy, serving as global...
-
CUSO Regulatory Affairs
1 week ago
New York, United States Credit Agricole Full timeSummary: The Regulatory Affairs team is responsible for coordinating and facilitating communications between the Bank and its various regulators on behalf of all US business operations and entities, as well as for coordinating the regulatory remediation efforts within the region. The team is primarily responsible for all interaction with regulatory agencies...
-
Regulatory Affairs Consultant
2 weeks ago
New York, United States Connect Life Science Full timeRegulatory Affairs Consultant Cambridge MA, Remote with occasional site time Medical Device 6 month contract - 40 hours per week Competitve hourly rate A MedTech company based in Massachusetts specializing in Class 2 Medical Device solutions are looking to hire a contractor for a 6-month renewable contract to support with product submissions in multiple...
-
VP, Regulatory Affairs
3 weeks ago
New York, United States Scismic Inc Full timeJob DescriptionJob DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs. Their vision is to build a specialty, hospital-focused radiotherapeutics company that...
-
Director, Regulatory Affairs
3 weeks ago
New York, United States Scismic Inc Full timeJob DescriptionJob DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs. Their vision is to build a specialty, hospital-focused radiotherapeutics company that...
-
Director, Regulatory Affairs
2 weeks ago
New York, United States Scismic Inc Full timeJob DescriptionJob DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs. Their vision is to build a specialty, hospital-focused radiotherapeutics company that...
-
VP, Regulatory Affairs
2 weeks ago
New York, United States Scismic Inc Full timeJob DescriptionJob DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs. Their vision is to build a specialty, hospital-focused radiotherapeutics company that...
-
Director of Compliance and Regulatory Affairs
3 weeks ago
Harrison, New York, United States Somnia, Inc. Full timeOverview: Director of Compliance and Regulatory Affairs Overview The primary function of this position is to direct and provide oversight of Somnia’s Compliance and Regulatory Affairs Program. The individual will be responsible for planning, implementing, and managing a compliance and regulatory affairs program for Somnia and its affiliated...
-
VP Regulatory Affairs
4 weeks ago
New York, United States Discera Search Full timeLead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next.Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and strategy for these early...
-
VP Regulatory Affairs
4 weeks ago
New York, United States Discera Search Full timeLead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next.Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and strategy for these early...
-
VP Regulatory Affairs
4 weeks ago
New York, United States Discera Search Full timeLead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next.Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and strategy for these early...
-
Head of Policy
7 days ago
New York, United States MSCI, Inc. Full timeThis role is a relatively new function at MSCI and is an exciting opportunity for an enthusiastic self-starter to create, and maintain, a program for the identification, analysis and communication of policy developments. In particular, the successful Regulatory Affairs, Policy, Regulatory, Government, Leadership, Support, Business Services
-
Medicare Regulatory Compliance Specialist
17 hours ago
New York, United States NYC Health Hospitals Full timeMetroPlusHealth provides the highest quality healthcare services to residents of Bronx, Brooklyn, Manhattan, Queens and Staten Island through a comprehensive list of products, including, but not limited to, New York State Medicaid Managed Care, Medicare, Child Health Plus, Exchange, Partnership in Care, MetroPlus Gold, Essential Plan, etc. As a wholly-owned...