EU Regulatory Compliance Coordinator Job at Sport Vision Czechia s.r.o. (Praha)

Medior-Senior GRC Consultant - Regulatory and Compliance focus

We ensure that all operations, digital or otherwise, meet the latest quality and...

Location

Belgium , Brussels

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

5-8 years of experience in the Cybersecurity business landscape
Proficiency in Dutch and English is mandatory
Advanced knowledge of the 'cyber regulatory area'
Understanding of AI Act, DORA is a plus
Strong experience in performing Compliance Maturity assessments, Data Protection Impact Assessments and to apply Data protection by Design/By default and risk-based approach, perform quality legal compliance analyses and produce good quality reports
ISO27001 certification is a plus, experience in ITSRM, and a good understanding of compliance-oriented projects
Strong knowledge of PM roles and the ability to independently handle content-oriented missions
Client-oriented with the ability to navigate the EU and national regulatory environment, engaging with various stakeholders (regulators, EU, CISO, DPO)
A hands-on approach with a solution-oriented mindset, capable of effective communication within the business environment
Independence in client-oriented projects and adept at identifying opportunities

Job Responsibility

Lead regulatory compliance projects
Interpret complex legislation such as AI Act and DORA
Apply technical knowledge in cybersecurity to enhance the company’s security posture
Contribute to pre-sales activities
Draft RFPs
Understand the broader EU and national business landscapes

What we offer

Extensive career development opportunities
Dynamic network of 56,000 professionals
Wide array of offices to explore

Fulltime

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Director of Regulatory Affairs

ILIA is looking for a Director of Regulatory Affairs to join the team in buildin...

Location

United States , Laguna Beach; New York City

Salary:

160000.00 - 175000.00 USD / Year

ILIA Beauty

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree in a relevant field (e.g., Life Sciences, Chemistry, Cosmetic Science, Regulatory Affairs)
10+ years of regulatory experience in the cosmetic or personal care industry, with at least 3 years in a managerial or leadership role
In-depth knowledge of U.S. and international cosmetic regulations (e.g., FDA, EU, Health Canada), safety assessment practices, and industry standards
Strong analytical and problem-solving skills, excellent written and verbal communication skills, and the ability to work collaboratively across departments, vendors and government agencies
Proven ability to lead and mentor a team of regulatory professionals, fostering a high-performance culture focused on compliance and innovation
Strong network within regulatory agencies and industry associations
Ability to work in a fast moving, fast changing environment
This position may require occasional travel to meet with regulatory agencies, attend industry conferences, or other related travel

Job Responsibility

Develop and implement a global regulatory strategy that aligns with business objectives while ensuring product compliance and safety (e.g. market expansion, short and long-term regulation updates, etc.)
Responsible for ensuring that all products comply with relevant regulations and standards (e.g., FDA, EU Cosmetic Regulation, etc.) throughout their lifecycle, from product development to marketing and distribution
Collaborate and communicate effectively with internal and external teams including but not limited to
product development, research and innovation, all marketing functions, and quality assurance, to ensure compliance with domestic and international regulations
Oversee the preparation and submission of regulatory documents, including ingredient notifications, safety assessments, and product registrations
Oversee post-market surveillance, adverse event reporting, and recall management
Collaborate with product development, marketing, quality assurance, and supply chain teams to provide regulatory advice and guidance during product formulation, testing, and labeling
Coordinate with product marketing, product development and testing facilities to create claims substantiation protocols and consumer perception questionnaires
Review product labels, marketing materials, and communications to ensure compliance with advertising regulations and truthful representation of product benefits
Contribute to the utilization & advancement of our product lifecycle management (PLM) tool or internal tools to manage global registrations, claims substantiation, and documentation workflows

What we offer

Bonus Opportunity
Health Benefits - 100% employer-paid medical, dental & vision coverage
Flex Time Off - No cap on personal time off and paid company holidays
Seasonal Flex Days - Flexible scheduling to enjoy extra time under the sun during the Spring & Summer season
Parental Leave - Up to 18 weeks paid parental leave
401(k) - Save for your future with a 401(k) with a company match
Flexibility & Wellness Stipends - Monthly stipends to support remote work & self-care
Hybrid Work Model - Find your flow, working from home or from one of our offices
ILIA Products - Quarterly stipend to replenish your favorite products and try new ones

Fulltime

Senior Regulatory Specialist

The Senior Regulatory Specialist is responsible for planning, managing, and impl...

Location

United States , Burnsville

Salary:

100000.00 - 130000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in a scientific discipline or equivalent education/ training
5+ years’ Regulatory and/or Compliance-related experience in a regulated industry
Previous experience with US and EU medical device regulatory requirements including Quality Systems and clinical investigations standards
Experience with preparation, submission, and approval for medical devices is required
Strong communication skills, both verbal and written
Strong analytical and problem-solving skills, as well as a good background in the medical device development process
Demonstrated ability to effectively manage multiple projects and priorities
Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat

Job Responsibility

Develops domestic and international strategies for regulatory approval of company products
Coordinates, compiles, and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country-specific product registrations
Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review
Reviews product and manufacturing changes for compliance with applicable regulations and impact on regulatory filings
Represents RA on cross-functional product development, manufacturing, and clinical support teams and provides regulatory leadership and feedback throughout the product development cycle. Provides recommendations for how to overcome regulatory barriers
Provides technical reviews of supporting documentation for inclusion in regulatory filings
Supports Medical Device Reporting (MDRs) and Medical Device Vigilance Reporting
Represents RA on other cross-functional projects, which may include process changes and continuous improvement efforts
Meets defined goals and objectives through own initiatives, activities, and available resources with minimal supervision
Performs other related duties and responsibilities, as assigned

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Compliance Risk Management Officer

Serve as a Vice President for Independent Compliance Risk Management (ICRM) resp...

Location

Luxembourg , Bertrange

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Demonstrated knowledge in area of Business in focus i.e. Investor Services and Issuer of securities
Work experience in Regulatory Compliance
Knowledge of EU and Luxembourg laws, rules, regulations, risks and typologies applicable to Credit Institutions
Strong interpersonal skills for building strong relationships with stakeholders and engaging teams
Ability to work both independently and collaboratively and ability to navigate a complex organization
A proactive approach in communication, and strength in sustaining independent views
Strong oral communication and writing skills in interacting with non-executives and executive management and across several business lines and control functions
Must be a self-starter, flexible, innovative and adaptive
Advanced analytical skills
Excellent project management and organizational skills and capability to handle multiple projects at one time

Job Responsibility

Regulatory Change Management and Controls: prompt identification of new or amended regulations impacting Citi activities in Luxembourg
perform impact assessment of the regulations
initiate the regulatory intake for the change management requirements and processes
Regulatory Inventory: Ensure that the regulatory inventory is up to date at all times, mapped to the applicable functions and business lines, along with the regulatory control framework for existing requirements
Management Information: Coordinate with regional and product ICRM stakeholders for escalating relevant ICRM information to local senior management
Compliance reviews: Perform independent testing activities to assess the design and effectiveness of key controls designed to address compliance risk
Credible challenge: Perform independent credible challenge on the first line of defence activities
Advisory role: advise the first line of defence stakeholders on any compliance related matters impacting them
ICRM Training: Ensuring that country elements of the ICRM global training plan are current and reflect local regulations while providing a fresh perspective on local trends and emerging regulation
ensuring that the training delivery method is tailored to the requirements of the subject matter and audience

Fulltime

Compliance Risk Management Senior Analyst

Serve as a Compliance Officer for Independent Compliance Risk Management (ICRM) ...

Location

Netherlands , Amsterdam

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Knowledge of EU, Dutch, Belgian and Luxembourg Compliance laws, rules, regulations, risks and typologies
Must be a self-starter, flexible, innovative and adaptive
Strong written and verbal communication and interpersonal skills
Advanced analytical skills
Ability to work both independently and collaborate with team members and ability to navigate a complex organization
Excellent project management and organizational skills and capability to handle multiple projects at one time
Proficient in MS Office applications (Excel, Word, PowerPoint)
Excellent language skills: English, French and Dutch
Prior experience of having worked for a large international Bank
Bachelor’s degree

Job Responsibility

Regulatory Change Management and Controls: prompt identification of new or amended regulations, perform assessment of the regulation and initiate the regulatory intake for the change management requirements and processes, arising from new and amended laws, regulations, rules and other requirements and expectations from regulatory and enforcement authorities
Regulatory Inventory: Ensure that the Regulatory inventory is up to date at all times, mapped to the applicable business lines, along with the regulatory control framework for existing requirements. Ensure identification, impact assessment and implementation of all applicable laws, regulations, rules and related processes, controls and reporting that impact Citi activities in the jurisdiction
Management Information: Coordinate with ICRM stakeholders to obtain information for the ICRM management information to local senior management
Compliance reviews: Perform targeted assessments to assess the design and effectiveness of key controls designed to address compliance risk
Policies & Procedures: Draft and maintain local Compliance policies and procedures
ICRM Training: Ensuring that country elements of the ICRM global training plan are current and reflect local regulations while providing a fresh perspective on local trends and emerging regulation
ensuring that the training delivery method is tailored to the requirements of the subject matter and audience

Fulltime

Regulatory Affairs Officer

As a Regulatory Affairs Officer, you will be responsible for developing regulato...

Location

United Kingdom , Edinburgh

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

A relevant degree or equivalent experience in regulatory affairs
Previous experience in regulatory submissions and compliance within medical devices or related industries
Strong knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions
Excellent technical writing skills and proficiency in MS Office
Ability to work independently and collaboratively in a fast-paced environment
Exceptional attention to detail, time management, and problem-solving skills

Job Responsibility

Prepare and compile regulatory documentation and coordinate submissions for global markets, including US, EU, Canada, and others
Advise internal teams on data requirements for successful license applications
Develop and maintain product labelling requirements and liaise with stakeholders
Monitor regulatory changes and maintain compliance with ISO13485, IVD Directive 98/79/EC, IVD Regulation 2017/746, FDA CFRs, and other global standards
Maintain technical files and regulatory documents for multiple territories
Communicate effectively with regulatory authorities and external bodies
Support process improvements and provide guidance and training to team members

Fulltime

Customs and Trade Compliance Consultant

As a Customs and Trade Compliance Consultant, you would be responsible for advis...

Location

United Kingdom , Bedfont, Middlesex

Salary:

Not provided

Tradewin

Expiration Date

Until further notice

Requirements

At least two years’ professional experience in a trade compliance position
Significant hands-on experience managing international trade compliance matters
Comprehensive understanding of European Union laws and regulations
Strong project management skills, with advanced proficiency in Excel and related computer applications
Proven ability to engage with both internal and external stakeholders to collect information and coordinate projects, ensuring customer needs are met proactively
Demonstrated skill in developing performance metrics and assessing both internal operations and external service providers
Ability to work effectively under pressure, solve problems, and support teams in meeting or exceeding customer deadlines
Track record of establishing, implementing, and maintaining standards, while continuously seeking improvement opportunities
Positive attitude and outstanding communication abilities
A Bachelor's degree is preferred

Job Responsibility

Monitor regulatory changes affecting customs and trade compliance
Analyze import and export data for accuracy and compliance
Assist with classification and valuation of products
Guide clients through free trade agreements and special customs programs
Provide problem-solving and risk mitigation strategies
Communicate clearly with businesses to help them navigate the evolving global trade landscape
Collaborate and communicate effectively with both internal and external parties
Pursue improvements in procedures and services to enhance efficiency and cost-effectiveness
Support the sales process
Complete 52 hours of training per year as per company standards

What we offer

Employee Stock Purchasing plan
Employee discount programs

Fulltime

EU Regulatory Compliance Coordinator

Sport Vision Czechia s.r.o.

Location:
Czech Republic , Praha

Category:
Legal

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 10, 2026

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Medior-Senior GRC Consultant - Regulatory and Compliance focus