Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of...
The Regulatory Specialist is a part of Research and Development, this team is responsible for assessing ingredient safety and regulatory compliance, coordinating safety, micro, stability, compatibility and claims testing, ensuring product compliance with international cosmetic regulations, and advis...
Senior Regulatory Affairs Specialist. Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings. Prepare regulatory submissions for FDA 510(k) clearance and A2F submissions. Research regulatory requirements from FDA, CMDR, MDR, IVDR, and UK ...
Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Review reports of customer complaints and assess them for regulatory reporting. ...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. DUTIES AND RESPONSIBILITIES Regulatory Compliance - knowledge of fed...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Regulatory Affairs Specialist II:. ...
The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. Regulatory Compliance - knowledge of federal and municipal regulatio...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, CMC Regulatory Affairs, Biologics. ...
They are looking to bring on a Senior Director, Regulatory Affairs to the team. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions. Utilize deep knowledge of regulatory requireme...
Regulatory Affairs Manager - Permanent - Remote. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and p...
Reporting to the Senior Director of Regulatory Affairs, the Manager/Senior Manager, Regulatory Affairs will be responsible for strategic and administrative aspects of regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of highest quality, and ...
They are looking for a Director of Regulatory Affairs with experience to spearhead regulatory strategies for Class II and Class III Cardiology and/or Cardiovascular Devices. If you would like to learn more about this Director of Regulatory Affairs opportunity and have the desire to build and develop...
Senior Manager, Regulatory Affairs (Clinical). Meet has partnered with an exciting late-stage oncology biotech that is looking for a Senior Manager of Regulatory Affairs to join their team. You will support the preparation of major regulatory submissions (IND's, NDA's, BLA's). You will serve as the ...
As the Regulatory Affairs Director, you will have the opportunity to lead Allogeneic trials – the most innovative in history! This role allows you to bring past Regulatory knowledge to the table, while also be creative in strategic discussions and decisions. Regulatory Affairs experience within a ph...
The Senior Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to ensure compliance with U. Extensive knowledge of regulatory requirements, including ICH and regional guidelines, and an understanding of current global and regional trends in regulatory affai...
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of...
The Executive Director/Senior Director of Regulatory Affairs will also oversee the preparation of all regulatory documents and submissions, mentor junior team members, and stay updated on changes in FDA and EU regulations. Executive Director/Senior Director of Regulatory Affairs. If you or someone y...
As the Senior Project Manager and Estimator of Renewable Energy at Bragg Companies, you will play a crucial role in overseeing and managing the successful execution of our renewable energy projects from conception to completion. You will be responsible for estimating project costs, coordinating reso...
The Compliance Specialist exercises considerable latitude in performing contract and/or procurement analysis, mentorship and advising to others, to ensure compliance to regulations, contractual requirements and Company policy. We have an exciting opportunity for a Compliance Specialist with our clie...
Support the Project Manager to develop and maintain customer relationships. Supports the Project Manager to identify and resolve issues/conflicts. Monitor, document, and report project progress (daily, weekly, monthly), including. Project time & schedule progress. ...
Environmental Permitting and Compliance Specialist). Environmental Permitting and Compliance Specialist). Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our missio...
Utilize MS Project and other project management tools to monitor project budgets and timelines, ensuring projects are delivered on time and within budget. We seek an experienced Senior HVAC Project Manager to oversee large-scale commercial HVAC projects in Orange, CA. Job Title: Senior HVAC Project ...
Regional Compliance Specialist. Assist in turning around low-performing divisions' compliance numbers and contribute to the continuous improvement of the company’s compliance program and processes. In collaboration with Region Safety Directors, GMs, and division safety, develop and implement strateg...