Regulatory Affairs Specialist (m / f / d) - Intensive Care Medicine / Peritoneal Dialysis

GULP – experts united; Bad Homburg vor der Höhe; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

A leading company in the medical device industry is seeking a Regulatory Affairs Expert to manage global regulatory documentation for intensive care and peritoneal dialysis products. The ideal candidate will have a strong technical background, several years of relevant experience, and expert knowledge in regulatory standards within the medical device sector.

Leistungen

Option of permanent employment

30 days vacation

Christmas and vacation bonus

Very good induction training

Home office days

Employee benefits program

Top working atmosphere

Qualifikationen

• At least 1 year of experience in regulatory affairs or quality assurance for medical devices.
• 2+ years in development, manufacturing, and control of medical devices.
• Familiarity with ISO 13485, ISO 14971, FDA regulations.

Aufgaben

• Manage global regulatory documentation, including submissions and approvals.
• Ensure compliance with standards and conduct conformity assessments.
• Coordinate regulatory strategy and communication across markets.

Kenntnisse

Regulatory knowledge of global registration

Quality management standards

Risk management standards

Ausbildung

Doctorate, MBA or relevant specialist training

Jobbeschreibung

We are looking for an experienced Regulatory Affairs Expert (m / f / d) in the field of intensive care / peritoneal dialysis with several years of professional experience at our Bad Homburg site.

Here's what we offer

• Option of permanent employment
• 30 days vacation
• Christmas and vacation bonus
• Very good induction training
• Home office days
• Participation in the employee benefits program with over 2600 online stores (travel, car, fashion, technology, etc.)
• Top working atmosphere with the client
• Manage the creation, maintenance and approval of global regulatory documentation (e.g. technical files, registration dossiers, labeling, IFUs).
• Support global product registrations, renewals and submissions, including the compilation of STED files, declarations and certificates of free sale
• Ensure compliance with applicable standards, conduct conformity assessments and reconcile product risk classifications
• Provide regulatory information for design changes, development projects and change control processes
• Coordinate global regulatory strategy, activities and communication across all markets
• Lead regulatory impact assessments, change implementation and stakeholder alignment
• Support the creation and review of declarations of compliance, marketing materials and product-related documentation
• Contribute to clinical evaluation content and provide expert opinions and risk assessments
• Assist with the registration of manufacturing sites, kits and commercial goods; assist with tenders and pharmaceutical device submissions

Your profile

• Technical / engineering / scientific background (doctorate, MBA or relevant specialist training)
• At least 1 year of professional experience in regulatory affairs or quality assurance for medical devices / pharmaceuticals
• At least 2 years of experience in the development, manufacturing and control of medical devices / pharmaceuticals
• Familiarity with quality management and risk management standards (e.g. ISO 13485, ISO 14971, EU GMP guidelines, FDA 21 CFR §820.250)
• Understanding of the Medical Device Regulation (MDD 93 / 42 / EEC, MDR 2017 / 745)
• Knowledge of internal / external processes and requirements of corporate quality management
• Expert knowledge of sterilization processes, cleanroom requirements and validation methods
• Regulatory knowledge of global registration