Regulatory Affairs Professional for Medical Devices

Vor 5 Tagen


Hannover, Niedersachsen, Deutschland Aristo Group Vollzeit

Aristo Group is a project and personnel consulting company specializing in the Life Science sector. Our goal is to find the 'perfect match' for our customers and candidates.

We are currently looking for a Regulatory Affairs Specialist (m/w/d) for the Hannover area.

Responsibilities:

Execute and assist with medical device registration for EMEA and China

Assist with internal regulatory review processes for product life cycle and product development to ensure conformity assessment according to MDR

Implement and improve internal records systems, particularly regulatory files (Technical File according to MDR Annex II & III or STED)

Support Post-Market Surveillance (PMS) activities according to MDR

Develop, review, and implement Standard Operating Procedures (SOPs)

Evaluate regulatory history, guidelines, policies, and regulations specific to products and markets

Support the evaluation of regulatory impact on current and new products

Contribute to the development of regulatory strategies and updates based on regulatory changes

Communicate effectively with customers and regulatory bodies

Qualifications:

Bachelor's degree (BS) in Engineering, Physics, Chemistry, Biology, or a related field

At least 3 years of experience in medical devices

Knowledge of applicable international regulations and standards, including MDD and/or MDR, ISO 13485, MEDDEV 2.12/1, and Medical Device Coordination Group (MDCG)

The estimated salary for this position is approximately €50,000 - €70,000 per year, depending on qualifications and experience. The Aristo Group offers a dynamic work environment and opportunities for professional growth.

The ideal candidate will have excellent communication skills, be proactive, and possess a strong understanding of regulatory requirements for medical devices. If you are motivated and eager to contribute to a fast-paced team, please apply for this exciting opportunity



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