Regulatory Submission Associate

• Type: Full-time, 40 hours/week
• Duration: 12 Month Fixed Term Contract (FTC)
• Start: Pipeline Project pending client go-ahead
• About the Business

Our client is a global leader in advancing healthcare technologies, specialising in the development, manufacturing, and commercialisation of innovative medical devices spanning cardiac, vascular, and neuromodulation therapies.

With an enduring commitment to quality and regulatory excellence, their solutions empower clinicians to improve patients' lives across markets worldwide.

Role Summary

As a Regulatory Submission Associate (EMEA), you will support vital regulatory activities across study startup, maintenance, and closeout phases for medical device clinical studies within the EMEA region.

Your contributions will focus on the preparation and submission of documents to Ethics Committees (EC) and Competent Authorities (CA), with a particular emphasis on country- and site-specific Patient Informed Consent adaptations.

You'll be instrumental in ensuring regulatory approvals are secured within forecasted timelines.

Key Responsibilities

• Coordinate and manage regulatory submissions for medical device clinical studies across EMEA, including Ethics Committees, Competent Authorities, and other applicable national bodies.
• Manage the preparation, review, and localisation of clinical trial documentation to meet country-specific regulatory requirements.
• Coordinate the translation and linguistic review of essential study materials, ensuring appropriate regulatory and patient-facing terminology.
• Draft, review, and customise Patient Informed Consent documentation at site and country level, ensuring alignment with local regulatory and Ethics Committee requirements.
• Review clinical study protocols and translate complex technical information into clear, patient-friendly and regulator-appropriate language for submission documentation.
• Act as a key contact for Ethics Committees, Competent Authorities, and other regulatory bodies throughout the submission and approval lifecycle.
• Coordinate responses to regulatory questions and requests for additional information, working closely with Clinical, Regulatory, Legal, and other internal stakeholders.
• Support the adaptation and review of site-specific budgets and documentation in accordance with local requirements.
• Ensure regulatory and study documentation is accurately maintained within relevant electronic systems and clinical trial databases.
• Monitor changes to MDR, GCP, ISO standards, and country-specific clinical research regulations, communicating relevant updates to project teams.
• Identify potential regulatory or compliance risks and support the implementation of appropriate corrective and preventative actions.
• Provide guidance and regulatory training to internal teams, clinical study personnel, and external partners where required.
• Support the collection, review, and tracking of essential documentation required for site activation and study initiation.
• Work closely with Clinical Site Management and cross-functional teams to ensure regulatory milestones are achieved within agreed timelines.
• Provide support and knowledge-sharing to less experienced team members, including guidance on regulatory submission processes and operational activities.
• Required Qualifications
• Bachelor's degree or equivalent professional experience in Regulatory Affairs, Clinical Research, Life Sciences, Medical Devices, Pharmaceuticals, or a related discipline.
• At least 5 years of experience supporting regulatory activities associated with clinical research, preferably within the medical device industry.
• Strong practical experience managing clinical trial submissions and regulatory processes across EMEA.
• Solid understanding of EU MDR, GCP, ISO standards, and applicable national clinical research regulations.
• Native or near-native German language skills, with strong written and spoken English.
• Strong working knowledge of Microsoft Office, particularly Word and Excel, alongside clinical trial, regulatory, or document management systems.
• Previous experience supporting clinical investigations involving cardiovascular, vascular, cardiac, or neuromodulation medical devices is highly desirable.
• Ability to assess complex regulatory information, identify issues, and provide practical solutions within clinical research environments.
• Excellent written and verbal communication skills, with the ability to engage effectively with regulatory authorities and cross-functional stakeholders.
• Highly organised with strong attention to detail and the ability to manage multiple regulatory activities and deadlines simultaneously.
• Comfortable working independently while also collaborating effectively within international, matrixed teams.
• Preferred Qualifications
• Previous experience working within a global, multi-business-unit or cross-functional medical device organisation.
• Experience contributing to regulatory inspections, internal audits, or audit-readiness activities.
• Working knowledge of FDA regulations, US clinical trial requirements, and wider international medical device standards.
• Experience working within a global clinical research, regulatory operations, or clinical submissions function.
• Familiarity with electronic Trial Master Files (e TMF), regulatory information management systems, or other clinical documentation platforms.