Job Closed

This listing is no longer active.

Regulatory Manager, Early Access Programs

ComplianceComplianceFull TimeRemoteSeniorTeam 51-200Since 1998H1B No SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

59 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglish

Job Description

Regulatory Manager, Early Access Programs

Bionical Emas

• Provide strategic and operational regulatory expertise and support to the EAP division • Be the client point of contact for regulatory activities for multiple EAPs and attend regular client calls to provide regulatory updates as required • Develop Regulatory Strategy Reports at the start of each EAP • Manage and track all regulatory activities relating to set-up, maintenance and close-out of a live EAP • Develop key regulatory documents for cohort regulatory including medical writing where required • Prepare, collate and submit regulatory packages for cohort regulatory submissions in line with local requirements • Develop and maintain regulatory database of global EAP regulations and guidelines • Develop and maintain EAP regulatory SOPs • Support business development process as required through provision of regulatory expertise • Work closely with wider Bionical Emas Regulatory department to share learnings and to provide EAP expertise as required • Develop own external regulatory network relating to EAP Regulatory Affairs for the purpose of thought leadership, regulatory intelligence and continuous professional development

Job Requirements

  • Bachelor’s degree in a healthcare/science-related subject
  • Previous experience in a regulatory affairs within the pharmaceutical medicine environment
  • Experience within EAP would be advantageous

Benefits

  • 25 days of vacation
  • Vacation days purchasing scheme
  • 1 extra vacation day per each 3 years of service
  • Discretionary Annual Bonus
  • Sabbatical of 3 to 6 months (after 2 years of service)
  • Free food and beverages at all offices
  • Life Insurance
  • Health Insurance and Employee Assistance Programme
  • Employee Support Networks – help us continue to build on our inclusive culture
  • Flexible and hybrid work

Related Categories

Related Job Pages

More Compliance Jobs

VeroHR logo

Quality & Regulatory Specialist

VeroHR

We get people. You get success.

Compliance59 days ago
Full TimeRemoteTeam 11-50H1B No Sponsor

• Deliver quality and regulatory client projects focused on medical devices with software elements • Educate clients on why regulatory documentation is needed, not just what is required • Create, review, and structure medical device technical documentation • Support quality and design activities aligned to medical device regulations and standards • Help clients compile and organise documentation into regulator‑ready formats • Adapt internal templates to meet specific client and product needs • Lead and contribute to client meetings, guiding discussions with clarity and confidence • Liaise closely with software engineers, product teams, HR, and senior stakeholders • Work collaboratively with colleagues to deliver joined‑up, practical solutions • Manage and deliver multiple client projects simultaneously in a consulting environment

United Kingdom
£45K - £55K / year
Job Closed
ICON plc logo

CRA II

ICON plc

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients, and suppliers.

Compliance59 days ago
Full TimeRemoteTeam 10,001+Since 1990H1B No Sponsor

CRAII ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. What You Will Do: You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include: - Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. - Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. - Collaborating with investigators and site staff to facilitate smooth study conduct. - Performing data review and resolution of queries to maintain high-quality clinical data. - Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your Profile: You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience: - Bachelor's degree in a scientific or healthcare-related field. - Minimum of 2 years of experience as a Clinical Research Associate. - In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. - Strong organizational and communication skills, with attention to detail. - Ability to work independently and collaboratively in a fast-paced environment. - Willingness to travel as required (approximately 60%) What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

France
Reachdesk Ltd logo

Customs Compliance Consultant

Reachdesk Ltd

Reachdesk is a cutting-edge B2B gift and SWAG platform that allows companies to deliver e-gifts, gifts, and bespoke merchandise that build deeper connections with customers, prospects, and employees at the click of a button. We integrate seamlessly with sales and marketing tech stacks, enabling companies to deliver moments that matter at scale, globally, throughout the entire customer lifecycle. We are an equal opportunity employer and value diversity at Reachdesk. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, disability status, or any other protected characteristic.

Compliance59 days ago
Full TimeRemoteTeam 201-500

This is a 6-month contractor role, with the potential to extend on a month-to-month basis. This role is fully remote, however your available working hours must overlap with London 9am - 6pm or New York 9am - 6pm. About Us Reachdesk is the first truly end-to-end SaaS global gifting and swag platform, helping B2B companies create meaningful connections with prospects, customers, and employees while driving measurable ROI. We believe gifting is more than just a transaction. It is about building genuine human connections that fuel business growth. Whether engaging prospects, celebrating customers, or recognising employees, our platform makes it easy to deliver personalised gifts, branded swag, and memorable events and brand experiences at scale through automated sourcing, storage, and global delivery. Trusted by many of the most recognised names in technology and SaaS, Reachdesk integrates seamlessly with marketing, sales, and HR tech stacks and is powered by a global team with hubs in New York, London, and Lisbon. About the Role We are looking for an experienced contractor to support Reachdesk on a range of customs compliance projects across our global operations. This is a hands-on, high-impact contract role for someone who can quickly assess risk, improve processes, work across multiple stakeholders, and help us strengthen the way we manage customs and cross-border trade compliance in practice. You will partner closely with teams across Operations, Logistics, Marketplace, Product, Legal, and Finance, as well as external brokers, carriers, and warehouse partners. This role is best suited to someone who is practical, detail-oriented, commercially aware, and comfortable working independently in a fast-moving international environment. What You’ll Do Customs Compliance Projects - Support Reachdesk’s customs compliance work across import/export activity, customs documentation, product classification, valuation, country of origin, duties, and related operational controls. - Review existing customs processes and help design, improve, and document scalable compliance procedures. - Partner with internal teams and external logistics providers, customs brokers, carriers, and 3PLs to support compliant shipment flows and customs clearance. - Help investigate and resolve customs issues such as holds, clearance delays, documentation gaps, or shipment exceptions. - Assist with compliance for restricted items, sanctions-related considerations, and broader cross-border trade requirements where relevant. - Identify compliance risks within current and proposed operating models, and recommend practical mitigations. Cross-Functional Support - Work closely with Operations, Logistics, Marketplace, Product, Legal, and Finance to embed customs compliance into day-to-day processes and project decisions. - Support project work connected to new shipping lanes, markets, warehouse flows, sourcing models, or operational changes. - Help create and maintain internal documentation, including SOPs, guidance notes, controls, process maps, and audit-ready records. - Provide clear, practical guidance to internal stakeholders on customs-related requirements and best practices. Data, Controls, and Documentation - Support the maintenance and improvement of key customs-related data, including product classifications, origin information, shipment documentation standards, and related compliance records. - Help assess whether tools, automation, or systems changes could improve customs compliance workflows and reporting. - Assist with audit preparation, evidence gathering, remediation tracking, and general compliance project management where needed. About You - Significant experience in customs compliance, global trade compliance, import/export compliance, or a closely related cross-border trade role. - Strong working knowledge of customs requirements, import/export controls, HS classification, valuation, duties, origin, and international shipment documentation. - Experience working with customs brokers, freight forwarders, carriers, 3PLs, or other logistics partners. - Comfortable operating in a project-based role where priorities may evolve and where you are expected to work independently. - Able to spot risks, solve problems pragmatically, and balance compliance requirements with commercial and operational realities. - Strong documentation and process-design skills, with the ability to turn ambiguity into clear and workable procedures. - Confident working cross-functionally with legal, finance, operations, product, and external partners. - Experience in e-commerce, logistics, supply chain, fulfilment, or other high-volume cross-border environments is strongly preferred. - Familiarity with VAT or indirect tax concepts is helpful, but this role is primarily focused on customs compliance projects. Working Arrangement - 6-month contractor engagement, with the potential to extend on a month-to-month basis. - Fully remote. - Open globally, provided you can reliably overlap with London or New York working hours. Perks & Benefits - Competitive salary - A super-friendly, collaborative working culture populated by fun and dedicated people We are an equal opportunity employer and value diversity at Reachdesk. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, disability status, or any other protected characteristic. We process personal information submitted as part of your application in accordance with the Reachdesk Candidate Privacy Notice. Please review it here.

United States
VeroHR logo

Quality & Regulatory Specialist

VeroHR

We get people. You get success.

Compliance59 days ago
Full TimeRemoteTeam 11-50H1B No Sponsor

Are you passionate about quality, regulation, and building safe medical technologies? Ready to take the next step in your career within a growing consultancy where your expertise, curiosity, and impact genuinely matter? We’re looking for an enthusiastic and self‑motivated Quality & Regulatory Specialist to join our client's expanding Medical Device and International Standards team. You’ll support a diverse portfolio of clients developing medical devices with a strong software focus, helping them understand regulatory expectations and create the documentation and quality foundations required for market entry. If you enjoy working closely with key stakeholders for companies developing medical technologies, translating complex requirements into practical solutions, and genuinely helping people understand why quality matters, this could be the perfect role for you. About the opportunity: - This is a fully remote role with flexible working, designed to support a healthy work‑life balance. You’ll collaborate with a small, highly skilled team and meet in person for a team event at least quarterly (all expenses covered). - In this role, you will: - Deliver quality and regulatory client projects focused on medical devices with software elements - Educate clients on why regulatory documentation is needed, not just what is required - Create, review, and structure medical device technical documentation - Support quality and design activities aligned to medical device regulations and standards - Help clients compile and organise documentation into regulator‑ready formats - Adapt internal templates to meet specific client and product needs - Lead and contribute to client meetings, guiding discussions with clarity and confidence - Liaise closely with software engineers, product teams, HR, and senior stakeholders - Work collaboratively with colleagues to deliver joined‑up, practical solutions - Manage and deliver multiple client projects simultaneously in a consulting environment Essential experience: - Background in software‑based medical devices - Experience working within medical device quality management environments - Experience working closely with engineers, supporting, guiding, and helping shape documentation at the shoulder of development teams - Strong understanding of quality and regulatory expectations for medical devices - Confident communicator, able to engage with stakeholders from highly technical engineers to senior leadership - Highly organised, methodical, and detail‑driven - Comfortable working independently while contributing to a collaborative team Desirable experience: - Medical device technical documentation - ISO 13485 or other medical device standards - Gap analysis or internal auditing - Review of complex technical documentation - Process and procedure development - Exposure to AI or advanced software within medical devices - Client‑facing consultancy experience   Why you will love working here: - Salary between £45,000 and £55,000, depending on experience - 28 days annual leave, including bank holidays plus your birthday off - Fully remote working with quarterly in‑person team events (expenses covered) - Vitality Healthcare - Life Assurance (4x salary) - Training & Development: Ongoing professional development and support for further certifications - A values‑driven consultancy where quality, integrity, and collaboration are genuinely lived, not just written on a website - Progression opportunities as the medical device and international standards offering continue to grow

United Kingdom
£45K - £55K / year
Job Closed