In this role, you will help ensure that our products meet global regulatory requirements while supporting product development, market access, and ongoing compliance activities. You will work closely with cross-functional teams across R&D, Quality, Clinical, and Marketing, providing regulatory expertise that helps bring innovative technologies to patients worldwide.
This is an excellent opportunity for a regulatory professional who enjoys working in a dynamic, fast-paced environment, balancing strategic thinking with hands-on execution. Success in this role means becoming a trusted regulatory partner, ensuring high-quality regulatory submissions, maintaining global product registrations, and proactively navigating evolving regulatory requirements.
WHAT YOU WILL DO:
Prepare, compile, and submit regulatory documentation for new products and product changes, with a primary focus on Technical Documentation in accordance with EU MDR 2017/745.
Maintain global regulatory approvals and registrations, ensuring timely renewals, updates, and ongoing compliance.
Provide regulatory guidance and support to cross-functional teams, including R&D, Quality, Marketing, and Clinical Affairs throughout product development and change management activities.
Ensure compliance with applicable international regulations and standards, including FDA QMSR, EU MDR 2017/745, ISO 13485, and ISO 14971.
Monitor changes in global regulatory requirements and communicate potential impacts and recommendations to internal stakeholders.
Support internal and external audits and inspections, including interactions with regulatory authorities and notified bodies.
Maintain regulatory documentation, records, files, and databases in accordance with company procedures.
Collaborate with international partners to support global product registrations and regulatory submissions.
Contribute to regulatory activities that support product lifecycle management and continued market access.
Bachelors degree in a scientific, engineering, or related field.
1-3 years of Regulatory Affairs experience within the medical device industry.
Knowledge of global medical device regulations, including U.S. FDA and EU MDR requirements.
Experience preparing regulatory submissions, including Technical Documentation and international registrations.
Strong written and verbal communication skills, with the ability to communicate effectively across multiple functions.
Excellent organizational skills and the ability to manage multiple projects and deadlines simultaneously.
Ability to work effectively in a fast-paced environment with changing priorities.
Experience with regulatory management systems or electronic quality management systems (eQMS) – an advantage.
Experience with Class II and/or Class III medical devices – an advantage.
Familiarity with Software as a Medical Device (SaMD) or active medical devices – an advantage.
Masters degree and/or Regulatory Affairs Certification (RAC) – an advantage.
Prior involvement in regulatory strategy development – an advantage.
