Regulatory Affairs Consultant (MedTech) - Freelance

iO Associates - UK / EU; München; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An innovative MedTech company in southern Germany is seeking a skilled Regulatory Affairs Consultant to support their mission of advancing healthcare. This freelance role involves ensuring compliance with EU regulations and standards, developing regulatory strategies, and providing guidance to cross-functional teams. The ideal candidate will have a strong background in regulatory affairs, excellent analytical skills, and the ability to manage multiple projects. Join a forward-thinking organization dedicated to improving patient outcomes through cutting-edge technology and regulatory excellence.

Qualifikationen

• 5+ years of experience in regulatory affairs within the MedTech industry.
• Strong background in EU MDR and ISO 13485 compliance.

Aufgaben

• Develop and implement regulatory strategies for medical devices.
• Prepare and submit regulatory documentation to authorities.
• Liaise with regulatory bodies and provide guidance to teams.

Kenntnisse

Regulatory Affairs

EU MDR Compliance

ISO 13485 Knowledge

Analytical Skills

Problem-Solving Skills

Communication Skills

Ausbildung

Bachelor's degree in Life Sciences

Bachelor's degree in Engineering

Jobbeschreibung

Job Title : Regulatory Affairs Consultant (MedTech) - Freelance

Location : South Germany (20% On-site, 80% Remote)

Contract Duration : 6 Months

About the Client : Our client is a leading MedTech company based in the south of Germany, dedicated to advancing healthcare through innovative medical devices. Their mission is to improve patient outcomes and enhance the quality of life through cutting-edge technology and regulatory excellence.

Job Description : We are currently seeking an experienced Regulatory Affairs Consultant to join our client's team on a 6-month freelance contract. The ideal candidate will have a strong background in regulatory affairs within the MedTech industry and will be responsible for ensuring compliance with all relevant regulations and standards.

Key Responsibilities :

• Develop and implement regulatory strategies for medical devices.
• Prepare and submit regulatory documentation to relevant authorities.
• Ensure compliance with EU MDR, ISO 13485, and other applicable regulations.
• Liaise with regulatory bodies and notified bodies.
• Provide regulatory guidance to cross-functional teams.
• Monitor and interpret regulatory changes and updates.
• Conduct regulatory risk assessments and develop mitigation plans.

Requirements :

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• Minimum of 5 years of experience in regulatory affairs within the MedTech industry.
• In-depth knowledge of EU MDR, ISO 13485, and other relevant regulations.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and manage multiple projects simultaneously.
• Fluency in English; proficiency in German