Regulatory Compliance Specialist Job at Namirial

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...

Location

United States , Norwood

Salary:

80000.00 USD / Year

2San

Expiration Date

Until further notice

Requirements

Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
Proactive in identifying potential regulatory obstacles and developing effective solutions
Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
advanced degrees or certifications in regulatory affairs or quality assurance preferred

Job Responsibility

Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions

Energy Agreements & Compliance Specialist

Energy Agreements & Compliance Specialist to join the Long-term Optimization tea...

Location

Greece , Athens

Salary:

Not provided

Metlen Group

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Law, Economics
Master's degree in Energy Law, Energy Markets, or Regulation are an asset
4+ years of experience in energy contract management, regulatory compliance, market operations, or energy economics
Strong understanding of EU/Greek regulatory frameworks (REMIT, EMIR, MAR, NRA decisions, DAPEEP rulebooks, Balancing Regulation)
Knowledge of regional market frameworks (Balkan region) is considered a plus
High attention to detail, structured thinking, and ability to manage multiple priorities
Proficient in MS Office, especially Word
Proficiency in English (written & spoken) and fluency in Greek

Job Responsibility

Draft Renewable Energy PPAs and BESS Optimization Agreements
Prepare, review, and maintain standard and bespoke agreements for energy trading and aggregation activities
Take full ownership of the agreements process
Collaborate with Legal, Risk, and Market Operations teams
Develop and maintain internal compliance procedures, checklists, and reporting documentation
Monitor EU and Greek regulatory developments
Ensure compliance with REMIT, EMIR, and relevant market frameworks
Support the development and maintenance of strong relationships with key clients and partners

What we offer

Competitive remuneration package
Ticket Restaurant Card
Group Health Insurance Plan
Preferential household electricity plan
Pension Plan

Fulltime

Certification and Compliance Specialist

Our client, a large international leader in the iGaming industry, is hiring a Ce...

Location

Malta

Salary:

Not provided

Abroad Internships

Expiration Date

Until further notice

Requirements

Minimum three years of experience in certification management, compliance operations, or a closely related role
Previous iGaming experience is required
Highly organised, detail oriented, and comfortable managing multiple workstreams in parallel
Strong stakeholder management skills, with confidence communicating with external partners and internal teams

Job Responsibility

Support the successful delivery of all certification and audit activities, ensuring timelines, requirements, and documentation standards are met
Act as a primary point of contact for third party certification partners and test houses, working closely with the internal Gaming team
Review certificates, technical reports, and supporting documentation, escalating issues and risks promptly and clearly
Ensure each game’s documentation is complete, accurate, and compliant before release, including jurisdiction specific evidence and attachments
Become the internal go to person for certification processes, requirements, and best practice
Build strong knowledge of jurisdiction specific certification workflows and maintain a clear process for each market
Collaborate with Technical Compliance and other stakeholders to enable compliant content delivery with minimal friction
Maintain well organised certification records and repositories so documentation is accessible, traceable, and audit ready

What we offer

Competitive Compensation: You will receive a highly competitive compensation package, which includes a competitive base salary, performance bonuses, and other incentives, all reflective of your experience and contribution
Work-Life Balance: We value work-life balance and offer flexible working arrangements, recognising that achieving your best in your career requires a healthy balance between work and personal life

Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, ...

Location

United States , Saint Paul

Salary:

Not provided

Hemostasis Corp

Expiration Date

Until further notice

Requirements

Master’s degree in Regulatory Affairs and Services
Excellent written and oral communication skills
Demonstrate proactive and strategic thinking and be able to handle change and ambiguity

Job Responsibility

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review
Provide technical review of data or reports that will be incorporated into regulatory submissions
Analyze validation test data to determine whether systems or processes have met validation criteria
Study product characteristics or customer requirements and confer with management to determine validation objectives and standards
Identify deviations from established product or process standards and provide recommendations for resolving deviations
Develop validation master plans, process flow diagrams, test cases, and standard operating procedures
Create, populate and maintain the database for tracking validation activities, test results and validation systems
Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements
Prepare additional information or responses as requested by regulatory agencies

What we offer

401K
Dental
Life
Medical
Disability
Competitive salary and benefits package including health, life, retirement and related benefits

Fulltime

Senior Compliance Specialist

The candidate will support the Manager executing the annual compliance audit pla...

Location

Italy , Rome

Salary:

Not provided

Aegis FSI

Expiration Date

Until further notice

Requirements

Minimum five years of relevant experience in a compliance function at a financial intermediary, or in a consultancy firm with a focus on projects for banking groups and financial institutions
In-depth knowledge of the legislation governing financial intermediaries regulated by Article 106 of the Italian Banking Law (TUB) and the relevant Bank of Italy Circular 288/2015
Fluent English language skills, both written and spoken
Solid understanding of the core consumer credit provision processes and the roles of key business and control functions

Job Responsibility

Analyze regulatory changes, assess their impact on the business, and conduct subsequent gap analyses, providing ongoing consultancy support to business units on all compliance matters
Manage the periodic update and review of the compliance risk assessment
Lead the review and auditing of compliance within the consumer credit framework, with deep knowledge of specific regulations regarding usury, transparency, POG, conflicts of interest, and data privacy
Prepare and update compliance training content, and support the delivery of training courses across the organization
Review and update policies and procedures to ensure alignment with current compliance requirements

Fulltime

Compliance Specialist

The fundamental duties of the Compliance Manager are to monitor the company’s co...

Location

United States , Baltimore

Salary:

Not provided

Bay Property Management Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree w/ 3+ years of experience
Property Management and or Real Estate experience is a plus
Accounting experience is also a plus

Job Responsibility

Reviews new applicant files and recertification packages for regulatory eligibility
Provides support and guidance to on-site teams through e-mails and phone calls
Provides support and guidance to regional managers
Monitors continuing program compliance for properties
Reviews occupancy summaries and unit status reports
Prepares upcoming recertification summary
Reports audit findings to Regional Managers and assists management with recommendations to develop appropriate action plans to address identified risks
Responsible for the accurate and timely submission of all regulatory required reports
Updates monthly audit status report
Ensures sensitive data is secure and managed appropriately within the compliance department and throughout the organization

What we offer

401K
employee-paid health insurance
6 paid holidays
15 PTO days (after 90 day probationary period)

Regulatory Reporting Specialist

Solaris is a tech company with a full German banking license. Our Banking-as-a-S...

Location

Germany , Berlin

Salary:

Not provided

Solarisbank

Expiration Date

Until further notice

Requirements

5+ years of professional experience in the regulatory reporting environment of a bank or financial institution in Germany
Hands-on experience in preparing and submitting regulatory reports
Knowledge in CoRep and/or FinRep is highly desirable
Practical experience working with regulatory reporting software
Familiarity with OneSumX (Wolters Kluwer) or Regnology would be a significant advantage
Solid understanding of accounting principles is a strong plus
Skilled at independently analyzing new requirements and translating them into concrete implementation projects
A proactive individual who sees challenges as opportunities and enjoys improving processes
Excellent communication skills and thrive both when working independently and as part of a collaborative team
Fluent in both German and English (German is a mandatory requirement for this role)

Job Responsibility

Core Responsibility: Regulatory Reporting: You will take charge of preparing and submitting of regulatory and statistical reports under the CRR and KWG
Regulatory Implementation: You will continuously monitor regulatory developments, analyze their impact on our organization, and take responsibility for the implementation of new requirements
Technical Process Improvement: You will drive the enhancement and automation of our reporting systems by defining and testing data requirements and optimizing existing workflows
Collaboration and Quality Assurance: You will work in close partnership with the Finance department and our Financial Data Department to ensure the consistency and quality of the underlying data
Business Growth Support: You will provide regulatory guidance for the onboarding of new partners and products, ensuring all new activities are compliant from the start
Stakeholder Communication: You will be a point of contact for auditors and supervisors, fostering a professional and transparent relationship

What we offer

Home office budget
Learning & development budget of €1000 per year and a transparent growth framework to support your career goals
Competitive salary and a variable remuneration program
Monthly meal allowance
Deutschland ticket subsidy
28 vacation days, increasing by 2 days after 2 years and 3 days after 3 years with Solaris
Opportunity to work abroad for up to 12 weeks per year

Regulatory Reporting Specialist

The candidate will be in charge of preparing and submitting regulatory reports t...

Location

Italy , Rome

Salary:

Not provided

Aegis FSI

Expiration Date

Until further notice

Requirements

Degree-qualified with a strong track record (3+ years) in regulatory reporting in the financial services industry
In-depth knowledge and proven experience with European banking prudential regulations
Fluent English language skills, both written and spoken
Ability to perform accurately and efficiently under pressure and meet tight deadlines
Strong analytical skills with the ability to accurately identify, evaluate, and manage regulatory requirements

Job Responsibility

Lead the analysis and interpretation of prudential regulatory requirements from the Bank of Italy and EU, ensuring compliance and alignment with internal policies
Develop and implement strategic reporting solutions, while supporting group-level regulatory reporting in close collaboration with the Shared Services Regulatory Reporting Team
Evaluate the regulatory implications of new business initiatives and evolving prudential regulations (e.g. Basel 3+)
Contribute to effective regulatory change management by promoting cross-functional understanding and supporting the design and coordination of consistent implementation plans
Drive the financial planning and execution of high-impact strategic and regulatory projects
Contribute to the preparation and delivery of ICAAP documentation and Pillar 3 reports in line with regulatory expectations
Act as the primary point of contact for the external regulatory service provider, ensuring effective collaboration and service delivery

Regulatory Compliance Specialist

Namirial

Location:
Italy

Category:
Legal

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 05, 2026

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