Quality & Regulatory Specialist

Straumann Group is synonymous with premium quality, precision and innovation that deliver confidence in dentistry, backed by the world's largest scientific network. As a global leader in implant dentistry, we offer cutting-edge innovations that are considered industry benchmarks and disruptive technological breakthroughs, backed by long-term scientific evidence.

On this role, your primary responsibilities include:

• Ensure compliance of DW’s products with applicable regulations and standards throughout the product lifecycle and for all distribution markets
• Ensure that the technical documentation complies with regulatory requirements, including labeling
• Support the customer feedback & complaint handling process during root cause analysis and investigation
• Support PMS Postmarket Surveillance and CAPA exception management activities
• Be a member of product development teams to determine regulatory strategy with stakeholders, ensure regulatory submissions planning accuracy, and establish technical files to support registration activities.

Requirements

• Have a minimum 3 years of professional experience in regulatory affairs, preferably in the medical device industry
• Have technical writing skills
• Understand technical standards and regulations on Software as a Medical Device/Health Software; such as EU MDR, Principles of Software Validation, Artificial Intelligence, Risk Management, Cybersecurity
• Be change-resilient, flexible, and a problem-solving personality
• Have very strong communication skills of written and spoken English, ideally also in German.

What we offer you

• A unique opportunity to grow your career in a world market leader in dental technology.
• A collaborative and supportive work environment where innovation and creativity are encouraged.
• Access to cutting-edge technologies and methodologies
• Competitive compensation and benefits package.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.