Clinical Risk & Regulatory Affairs Consultant
Deegit
Review and approval of the clinical workflow definitions for the subject devices Identification of the clinical hazards and associated harms for the subject devices Estimation of the severity and probability of occurrence for the clinically related hazardous situation Development of the clinical benefit statements for the subject device Understanding of device development in an FDA regulated environment Experience with ISO 14971 risk management activities Experience with the post market medical device support (complaint or risk analysis) Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr
- A medical consulting firm is seeking a Clinical Subject Matter Expert (SME) to support device risk management activities. The ideal candidate will have a degree in a clinical field (RN, MD) and at least 10 years of clinical experience, particularly within an FDA regulated...Risk
$142.8k - $196.35k
...Principal Regulatory Affairs Specialist – Solventum Impact You’ll Make in this Role Serve as regulatory... ..., and relevant metrics. Support risk management, vigilance reporting, and other... ...and validation activities, including clinical requirements for medical devices. Experience...RiskRemote workWork visaFlexible hours$75.3k - $150.7k
...seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in... ...with applicable commercial and clinical regulations. Supports all business segment... ...regulations and submissions. Experience with risk management, design verification, or...RiskFor contractorsWorldwide$142.8k - $196.35k
## Principal Regulatory Affairs Specialist (Remote - United States)Applyremote type: Remotelocations... .... Guided by empathy, insight, and clinical intelligence, we collaborate with the best... ...of relevant metrics* Supporting risk management, vigilance reporting, and other...RiskH1bRemote workRelocation packageFlexible hours- ...HealthPartners is hiring a Program Manager, Clinical Risk Management. The Program Manager... ...standards of all applicable accrediting and regulatory agencies with the objective of... ...appropriate stakeholders Serving as a risk consultant to internal customers to prevent or minimize...Risk
$110k - $160k
...part of our great team! The Senior Regulatory Affairs Specialist will lead and execute... ...impact assessments and develops compliant, risk‐based regulatory strategies across product... ...development, operations, quality, clinical, manufacturing, and marketing teams, providing...RiskWork experience placementLocal areaFlexible hours- ...Regulatory Affairs Specialist This role is ideal for a regulatory professional with strong experience in FDA, Health... ...Maintain and update European technical files, including risk assessments, usability reports, and clinical evaluations Prepare and execute annual...RiskWork at office
- ...Director or Associate Director of Regulatory Affairs that will be responsible... ...compliance, provide consultation on regulatory aspects during... ...development, including preclinical, clinical, and manufacturing stages,... ...and mitigate regulatory risks, ensuring anticipated...RiskRemote work
- ...Associate Director, Regulatory Affairs - Pulsed Field Ablation (PFA) Work mode: Hybrid Onsite... ...initiatives. You will partner closely with R&D, clinical, quality, medical safety, operations,... ...initiatives Assess regulatory risks, timeline impacts, and decision trade-offs...RiskWorldwide
$114k - $210.9k
...Experienced Clinical Trial Manager - Full-Service Syneos Health is a leading fully-integrated... ...a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees... ...data and process, protocol execution risks and risk mitigations related to completion...RiskContract workFlexible hours- ...Lead operational execution of assigned clinical trials under both: In-house managed models... ...supporting and overseeing both Risk-Based Monitoring (RBM) strategies and traditional... ...to study design, risk profile, and regulatory expectations Ability to transition studies...RiskRemote work
- ...requirements of pertinent federal, state and local regulatory schemes in reference to all business... ...compliance practices and performs risk assessments. Analyzes existing policies,... ...Background in compliance, regulatory affairs, or similar Experience with large...RiskLocal area
- ...integrity, and genuine human connection. Our consultants don't just guide clients through... ...exposure to varied technologies, cultures, and regulatory expectations.Join a team that values... ...inspectionsAuthoring and reviewing SOPs, risk assessments (HACCP, FMEA), validation...RiskRemote workWorldwide
- ...POSITION SUMMARY The Regulatory Sustainability Analyst supports the organization's environmental... ...science, sustainability, regulatory affairs, or related field preferred * 2+ years of... ...interpretation, data governance, and risk assessment. * Demonstrated ability to read...RiskTemporary workLocal area
$60k - $75k
...at its Bloomington, MN office. This role ensures adherence to regulatory requirements and Servicing Agreements, coordinates audits,... ...improvements. Analyzing data to identify trends, inaccuracies, assess risks, and recommend solutions is a key component of this position,...RiskWork experience placementStart working todayWork at officeRemote workFlexible hours- ...V-Soft Consulting Group, Inc. is seeking a Sr. Clinical Trial Manager to lead various clinical trials in a hybrid environment. Candidates should have 10 years... ...relationships. Excellent communication and risk management skills are essential, along with knowledge...Risk
- ...The Specialist will also coordinate and manage state and federal regulatory examinations, supporting the Company’s commitment to strong... ...vendors, complete document gathering, due diligence reviews, and risk assessments. Assist business units in meeting contract renewal...RiskContract workWork at officeLocal areaRemote work
- ...TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a... ...redefine expectations in the treatment of aortic stenosis. Our Clinical and Regulatory Affairs teams play a critical role in supporting clinical research...RiskTemporary workLocal areaWorldwideFlexible hours
$183k - $228.8k
...A leading medical technology firm is seeking a Senior Advisor in Regulatory and Clinical Affairs to guide regulatory strategies for product approvals in the U.S. This remote role requires at least 15 years of experience within an FDA environment, strong communication skills...Remote work- ...organizational priorities, capital strategies, regulatory requirements, and patient experience... ...Construction, Plant Operations leaders, clinical and operational executives, and external... ...maintenance mitigation, and utility risk management. Support emergency preparedness...RiskContract workLocal area
$106k
...contribute professionally and personally. The Senior Regulatory Affairs Specialist originates appropriate documents to... ...Design Control process Provide Regulatory support for risk management activities and clinical evaluation Develop Regulatory Strategies for new...RiskTemporary workWork experience placementWork at officeLocal areaWorldwide$102.1k
...employees experience every day. This Regulatory Affairs Principal role supports the review and... ...interventional cardiology. The role applies a risk-based regulatory mindset to help ensure... ...claims are supported by appropriate clinical, performance and/or bench evidence and...RiskHourly payWork at officeLocal areaShift work3 days per week$75.3k - $150.7k
...Senior Regulatory Quality Specialist Abbott is a global healthcare leader that helps people... ...decisions Evaluate regulatory risks of division policies, processes, procedures... ...research and development/support, scientific affairs, operations, or related area....RiskWork experience placementShift work$91.7k - $163.7k
...while Caring. Connecting. Growing together. Job Description - Regulatory Adherence Consultant - Regulatory Finance - Minnetonka, MN (2360955) At... ...Regulatory Accounting & Reporting, and vendors to manage risk, resolve issues, and continuously improve regulatory and data...RiskMinimum wageFull timeWork experience placementWork at officeLocal area$103k - $128.75k
...efficiently for all Minnwest Subsidiaries. Prepares and submits selected regulatory compliance reports for all subsidiaries. Duties and... .... Assist the internal auditors in developing an annual risk-based compliance audit ensuring that those areas with greatest...RiskTemporary workWork at officeMonday to Friday$85k - $125k
...regulations and internal policies. The Trust Compliance Officer will maintain effective compliance policies and procedures to minimize risk and promote compliance within the organization. Success is defined primarily through maintaining the highest levels of compliance...RiskWork at officeRemote work$61.5k - $86.21k
...auditing, monitoring, training, policy management, investigations, risk assessments) supporting key compliance controls and the... ...benchmarking Assist with external and internal compliance, payer and regulatory audits, reviews, attestations and assessments Assist with...RiskHourly pay- ...Client Reporting Regulatory Consultant Our client is seeking a Client Reporting Regulatory Consultant with deep experience across client reporting... ...enhancements to improve efficiency and reduce operational risk Partner with technology, operations, compliance, product,...Risk
$90k - $121.3k
...-MN-Saint Paul | US-WI-Milwaukee Category/Function Risk/Security Position Type Regular Full-Time Requisition... ...point of contact for assigned lines of business and/or regulatory topics. This individual is responsible for pro-actively advising...RiskFull timeWork experience placementWork at office- ...) with leadership expertise to join our team as consultants providing interim leadership and operational support... ...providing stability and guidance in areas like regulatory compliance, staffing challenges, turnover, and risk mitigation. Key Responsibilities: Serve as...RiskInterim roleMonday to FridayWeekend work
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