Lead and oversee the Nextern's Quality and Regulatory functions, ensuring full compliance with applicable quality and regulatory standards.
Requirements
- Bachelor’s degree in BS/MS in Life Sciences, Business Administration, or related fields.
- 5 + years of experience in managerial roles for international medical device/pharma companies.
- 10 or more years of experience in highly regulated industries.
- Experience supervising engineering-level or coordinator-level personnel.
- Advanced knowledge of FDA medical device regulations and ISO 13485.
- Proficient in Microsoft Office (Excel, Outlook, Word); ERP systems (EPICOR) knowledge is a plus.
- Strong analytical and organizational skills.
- Excellent communication skills at all organizational levels.
- English proficiency at C1 level.
- Must demonstrate value-adding competencies in establishing collaborative relations.
Benefits
- Highly competitive compensation package