Regulatory Affairs Manager (m/f/d)

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Regulatory Affairs Manager (m/f/d)

Summary

In this position you coordinate and manage regulatory activities to commercialize the Medical Devices manufactured and distributed by the Company in the International Area.

Essential Functions

• Participate on project development teams to ensure that appropriate regulatory strategies are communicated, and regulatory requirements are met
• Take care of the preparation and editing of the technical and formal documentation necessary to get registrations and keep them in compliance with product changes with a particular focus on the international Area
• Manage premarketing, maintenance and renewal regulatory activities for the manufacturing site in the international Region, in collaboration with the regional regulatory team
• Cooperate in the relationships with Vigilance Authorities, Competent Authorities and the National Government Agencies in Europe and in the International Area
• Distribute appropriate notifications for product approvals and report on the status of approvals to appropriate company functions
• Monitor, verify and review product documentation (Instructions for use, brochures, Company website, etc.) to ensure compliance with relevant law requirements
• Interface/correspond with government agencies, industry organizations, distributors, and international personnel to keep abreast of regulatory requirements
• Provide necessary/requested information and materials to government agencies, distributors, and international personnel to meet regulatory requirements
• Assist if required during facility audits/assessments by government agencies
• Keep up to a high level of knowledge and comprehension of laws and regulations impacting on Company products

Knowledge, Skills and Abilities

• Technical Scientific University master’s degree (e.g. Chemistry, Biology, Biotechnology, Pharmacy, etc.)
• RAPS Society RAC designation is a plus
• Several years’ experience in the field of Sanitary Regulation; product conformity obtained, at least in part, in Companies in the Pharmaceutical or Medical Device sectors
• Knowledge of international regulations (for example Asia, Middle East, Latin America etc.)
• Knowledge of standards and regulations related to medical devices (EUMDR, ISO 13485, 21CFR820)
• Knowledge of the fundamentals of SAMD, digital health or AI regulations
• Knowledge of the Windows Office package
• Fluent in English (spoken and written)
• Knowledge of other languages would be a plus
• Ability and experience in preparation of technical and formal documentation necessary for submission and assessment at Notified Bodies and / or Competent Authorities.
• Preparation of organizational procedures
• Attitude to interpersonal relationships, to efficient communication, written and oral; projects management

What we can offer you

In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:

• A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
• Exposure to a State-of-the-Art medical device development process, in close co-operation with international clinicians
• Competitive base salary
• Variable short-term & long-term incentives
• Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements

If you like the sound of the above and feel energized by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!