Director, Regulatory Affairs, Pre-Market
Director, Regulatory Affairs, Pre-Market
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Job Description
Job Description Summary
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch premarket submissions/registrations and postmarket compliance working closely with healthcare regulatory bodies globally. Interprets simple internal and external business challenges and recommends best practices to improve products processes or services. Stays informed of industry trends that may influence work.Job Description
Roles and Responsibilities
Leadership & Strategy
Lead and develop the European Regulatory Affairs team fostering a high-performance and collaborative culture.
Define and execute regulatory strategies aligned with GE HealthCares global objectives.
Represent Regulatory Affairs in cross-functional leadership forums and strategic initiatives.
Regulatory Compliance
Ensure compliance with EU MDR and other applicable European regulations.
Act as PRRC under MDR ensuring product conformity and regulatory documentation integrity.
Oversee regulatory submissions CE marking processes and interactions with Notified Bodies and Competent Authorities.
Operational Excellence
Drive continuous improvement in regulatory processes and systems.
Monitor regulatory changes and assess impact on GE HealthCares product portfolio.
Support audits inspections and regulatory due diligence activities.
Stakeholder Engagement
Collaborate with Quality Legal Commercial and Product teams to ensure regulatory alignment.
Provide expert guidance and training on European regulatory requirements.
Represent GE HealthCare in industry associations and regulatory forums as needed.
Required Qualifications
Bachelors or Masters degree in Life Sciences Engineering or related field.
Minimum 10 years of experience in Regulatory Affairs with significant exposure to European medical device regulations.
Proven leadership experience including team management and strategic planning.
Fluent inGerman and English(written and spoken).
Must be based in theEuropean Unionand meet the qualifications to act asPRRCunder MDR.
Strong knowledge of EU MDR IVDR and relevant guidance documents.
Excellent communication negotiation and stakeholder management skills.
Desired Characteristics
Experience working in a global or matrixed organization.
Familiarity with digital health technologies and software as a medical device (SaMD).
Ability to influence and lead through change.
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Additional Information
Relocation Assistance Provided: No
Required Experience:
Director
Employment Type
Full-Time
