Environmental Compliance Specialist managing compliance with environmental laws for natural gas projects in multi - state areas. Supervising consultants, preparing compliance reports, and conducting audits.
About the role
- Lead European pre-market regulatory affairs and PRRC for GE HealthCare. Oversee MDR compliance, CE marking, submissions, Notified Body interactions.
Responsibilities
- Provide regulatory strategy and direction for pre-market product launches and registrations
- Lead and develop the European Regulatory Affairs team and define regulatory strategies aligned with global objectives
- 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
- Monitor regulatory changes and assess impact on product portfolio
- Support audits, inspections, and regulatory due diligence activities
- Collaborate with Quality, Legal, Commercial, and Product teams and represent Regulatory Affairs in cross-functional leadership forums
- Provide expert guidance and training on European regulatory requirements
- Drive continuous improvement in regulatory processes and systems
Requirements
- Bachelor’s or Master’s 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 in German and English (written and spoken)
- Must be based in the European Union and meet the qualifications to act as PRRC under MDR
- Strong knowledge of EU MDR, IVDR, and relevant guidance documents
- Excellent communication, negotiation, and stakeholder management skills
- Experience working in a global or matrixed organization (desired)
- Familiarity with digital health technologies and software as a medical device (SaMD) (desired)
- Ability to influence and lead through change (desired)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Compliance Analyst ensuring adherence to Federal Energy Regulatory Commission and ERCOT standards. Collaborating with various teams to manage compliance documentation and processes.
Manage compliance testing for Manulife within the Canada Segment team. Analyze key business controls and recommend improvements for compliance in financial institutions.
Senior Gas Pipeline Compliance Analyst maintaining safe, reliable natural gas operations at Enbridge. Analyzing regulations and partnering with teams for federal and state compliance.
Regulatory Analyst managing compliance obligations associated with regulatory requirements at Tallgrass, an energy infrastructure company. Involved in preparation, analysis, and administration in relevant areas.
Trainee supporting product compliance and legal regulation at ZF, engaging in training activities and various legal assistance tasks. Collaborating with experts on compliance projects.
VAT Compliance Specialist managing VAT - relevant data and ensuring compliance in an international team. Collaborating with various departments to maintain data quality and support documentation processes.
Working Student supporting the VATrules Team with data management and documentation processes. Engaging in VAT compliance and improving data structures in a hybrid work environment.
Specialist II in Regulatory Affairs preparing and maintaining global submissions for conducting clinical investigations. Collaborating with engineering and regulatory teams to ensure compliance with worldwide regulations.
Senior Lead Expert Regulatory managing bank regulatory communication and requirements at leading German bank LBBW. Overseeing compliance, analysis, and decision - making within financial regulatory frameworks.