Global Market Access Regulatory Specialist

Job summary

The role involves supporting worldwide Medical Device product registrations and ensuring compliance with relevant regulations. The position is based in the Corporate Quality department, working closely with various stakeholders both internally and externally.

Qualifications

• Relevant master’s or bachelor’s degree in Medical Market Access or related field.
• Experience with global Medical Device product registration approval processes.
• Knowledge of EU MDR, ISO 13485, and other medical device standards and regulations.
• Strong stakeholder management skills.
• Excellent collaboration and communication abilities in an international setting.
• Attention to detail and ability to meet deadlines.
• Proficient in English, both oral and written.
• Experience with Medical Device submissions and communication with authorities is advantageous.
• Project management experience is a plus.

Responsibilities

• Manage product registration cases for Medical Devices class I and IIa globally.
• Submit technical file documentation for tenders and reimbursement approvals.
• Respond to inquiries from authorities regarding technical file documentation.
• Serve as Market Access Subject Matter Expert for specific markets.
• Collect and develop technical file documentation.
• Order legalization of documents and Free Sales Certificates.
• Contribute to the development and maintenance of Market Access processes, work instructions, and templates.
• Participate in quarterly PI planning and contribute to audits.

Skills

• Strong stakeholder management and collaboration skills.
• Attention to detail and ability to meet deadlines.
• High-level proficiency in English.

Education

• Master’s or bachelor’s degree in a relevant field.

Tools

• Familiarity with regulatory compliance tools and documentation processes.