Lead regulatory compliance initiatives for advanced medical technologies at Novanta, driving strategic approvals and ensuring adherence to global standards from our Berlin hub.

Join Novanta as Lead Regulatory Affairs Specialist (m/f/d)

Novanta is a leading global supplier of precision photonic and motion control components used in advanced medical, industrial, and life sciences applications. We're seeking a seasoned Lead Regulatory Affairs Specialist to join our Berlin team and spearhead our regulatory strategy for innovative medical devices and technologies.

Key Responsibilities:

• Develop and execute global regulatory strategies for product development and market access
• Lead preparation and submission of regulatory dossiers (e.g., Technical Files, Design Dossiers, STED) to Notified Bodies and authorities
• Oversee compliance with evolving regulations including EU MDR/IVDR, FDA QSR, and Health Canada requirements
• Mentor and manage a team of regulatory professionals, fostering a culture of excellence
• Collaborate with R&D, Quality, and Clinical teams to integrate regulatory requirements early in the product lifecycle
• Conduct gap analyses, audits, and risk assessments to ensure ongoing compliance
• Represent Novanta in interactions with regulatory agencies and industry groups

This remote contract role offers the flexibility to work from Berlin or remotely within Germany, with opportunities for high-impact leadership in a cutting-edge industry. If you thrive in a fast-paced environment and have a passion for regulatory innovation, apply now!

• Master's or PhD in life sciences, pharmacy, engineering, or related field
• 7+ years of experience in regulatory affairs, with at least 3 years in a leadership role within medtech or pharmaceuticals
• Deep knowledge of EU MDR/IVDR, FDA regulations, and international standards (ISO 13485, etc.)
• Proven track record of successful product submissions (CE marking, 510(k), PMA)
• Strong project management skills and experience leading cross-functional teams
• Excellent communication skills in English and German; ability to liaise with authorities
• Familiarity with quality management systems (QMS) and risk management (ISO 14971)

• Competitive monthly salary in the range of €6,500 - €9,500
• Comprehensive health and dental insurance
• 30 days of paid vacation plus public holidays
• Flexible remote work options with occasional travel
• Professional development budget for certifications and conferences
• Company pension scheme and employee assistance program
• Modern home office setup allowance