Join the team!

We are looking for a Regulatory Affairs Consultant (m/f), 40 hrs/week, for our office in Vienna, Austria. Your main responsibilities

• Dealing with and responding to routine regulatory queries for information and documents in a timely, priority driven manner.
• Prepare, compile, review and/or submit regulatory documentation to regulatory authorities and Notified bodies.
• Handle licensing and post licensing procedures on behalf of clients including clinical Trial Applications, National, Mutual Recognition and Centralized Applications, medical device CE marking and food supplement notifications.
• Complete International product registrations and export certifications as requested by clients and international regulatory agencies in the EU and in third countries.
• Dossier and development gap analysis (drugs, food supplements) maintain current technical files and declarations of conformity in accordance with the Medical Device Directives.
• Respond to customer queries and questionnaires for regulatory information.

Required experience / skills / education

• Master’s degree (PhD preferred) in a relevant subject: Biotechnology, chemistry, biology or a similar background.
• 3-5 years experience in a similar position.
• Computer proficiency and adaptability working with a variety of databases, word processing, spreadsheet, etc.
• Ability to create effective reports and analysis and communicate them in a timely and effective manner.
• Ability to work in a team environment with shifting priorities and requirements.
• Project management skills.
• Ability and willingness to learn legal aspects of drug, medical device and food registrations.
• Proficient in English and German.
• Willingness to work at client sites in Europe.

Salary will be based on experience but will meet the legal requirements according to the Austrian laws and regulations.

We are looking for a (Junior) Regulatory Affairs Consultant (m/f) with a special focus on Medical Devices, 40 hrs/week, for our office in Vienna, Austria. Your main tasks

• Lead, organize and support key regulatory projects / tasks and regulatory compliance initiatives
• Support preparation of regulatory submissions, license renewals and registrations for clients and work with international authorities
• Work with the regulatory agencies third-party accreditation bodies
• Organize and maintain regulatory documentation to meet regulatory requirements
• Provide regulatory input to product development projects

Requirements

• Master degree or equivalent in Regulatory Affairs, Natural Sciences or Engineering and professional experience in the area of Medical Devices Regulatory Affairs or Quality Management for Medical Devices
• At least 3-5 years medical device or regulatory affairs work experience is required.
• EU Medical Device Regulation 2017/745, MDD 93/42 and familiarity with harmonized standards such as EN ISO 13485, EN ISO 14971 or MEDDEV guidelines. Knowledge of the new Medical Device Regulation (EU) 2017/745 and project management skills is an advantage.
• Excellent English (spoken and written) is required, advanced German strongly preferred. Other languages a plus.
• Good written and verbal communication skills
• Ability to be flexible and acceptance to travel
• Eager to learn, attention to detail, proven problem-solving & organizational skills, as well as a collaborative personality

Our offer

• Working in a dynamic, cooperative and global environment
• Flexible working hours
• Personal and professional growth opportunities
• Possible future international assignments
• Attractive salary, extensive benefits and pension plan

The salary for this position will meet the minimum legal requirements but higher salaries are negotiable based on experience and for the right candidate.