Aktuelle Jobs im Zusammenhang mit Medical Device Regulatory Expert - Hannover, Niedersachsen - Barrington James
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Medical Device Regulatory Expert
vor 3 Monaten
Job Title: Regulatory Affairs Specialist
Position Overview: We are collaborating with a prominent Medical Device organization seeking a Regulatory Affairs Specialist to enhance their esteemed team. The selected candidate will be instrumental in overseeing and facilitating internal regulatory review processes to ensure adherence to compliance standards.
Core Responsibilities:
- Assist in the registration process of medical devices across various regions, including EMEA, Russia, China, and the United States.
- Implement internal regulatory evaluations throughout the product lifecycle and development phases to comply with MDR standards.
- Improve and maintain internal documentation systems, particularly regulatory files such as Technical Files in accordance with MDR Annex II & III or STED.
- Conduct Post Market Surveillance (PMS) activities to align with MDR requirements.
- Support the creation, review, and execution of Standard Operating Procedures (SOPs).
- Examine and assess the regulatory history, guidelines, policies, and regulations pertinent to products and markets.
- Assist in evaluating the regulatory implications for both existing and new products.
- Contribute to the formulation of regulatory strategies and their updates in response to regulatory changes.
- Effectively communicate, both in writing and verbally, with clients and regulatory authorities.
Reporting Structure:
- Reports directly to the Senior Regulatory Affairs Manager.
Qualifications:
- Bachelor's degree (BS) in Engineering, Physics, Chemistry, Biology, or a related discipline.
- A minimum of 3 years of experience within the medical device sector.
- In-depth knowledge of international regulations and standards, including MDD and/or MDR, ISO 13485, MEDDEV 2.12/1, and MDCG guidelines.
- Fluency in English and German.
