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Senior Regulatory Specialist - Med Device

Manufacturing / Production
Danielle Francois
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Job Reference: JO-2104-65739_1620125007


Are you an experienced Regulatory Specialist with deep domain experience in the Medical Device industry? I am working on an interesting and unique role that will suit a candidate who enjoys research, writing and developing and sharing specialist knowledge.

My client is a regulatory solutions provider with specialisms in several areas including Med Tech, Life Sciences and Consumer Goods.

In this role, the Regulatory and Requirements specialist will monitor global regulatory developments, track regulatory developments globally and integrate that information on the online database.

While the company is based in Cork the position will be REMOTE and is OPEN to candidates in any location in Ireland.

Key Duties in this role include

· Monitoring regulatory developments for geographies and product groups with a specific focus on Medical Device, develop and maintain a robust bank of sources of regulatory information utilising automatic monitoring tools to maximise efficient and prompt capture of regulatory information Research

· Conduct research in the field of global regulations and standards, taking on more complex and technical research tasks, with a particular focus on global Medical Device regulations research and prepare specialised reports for clients.

· Enter Regulatory and supporting source detail on to the company's specialist platform ensuring all information is accurate in addition to the drafting of clear, well written, accurate summaries on key details in text, underpinned with an appreciation of clients' needs.

· Possess strong knowledge and understanding of all areas of coverage particular emphasis on global Medical Device Regulations.

· Become the go-to person for the Medical Devices Topic area and answer queries on the content from within the team as well as externally via our "Ask Our Experts" function.

· Help the organisation become recognised as a trusted source on Medical Device regulation and build brand recognition in this regard by the creation of articles, white papers, presentation of webinars related to Medical Devices.

· Provide guidance & answer queries on the Medical Devices Topic both to within the team and externally e.g., the sales team & clients.

Qualifications, Experience & Skills

· Degree in Law, Life Sciences or Science as a minimum.

· Minimum of 3-4 years experience in Medical Device compliance and regulatory environment.

· Significant knowledge of global medical device regulations covering areas such as safety & efficacy, conformity assessment, technical documentation; labelling; record-keeping, packaging; mandatory unique device identification (UDI) mechanisms, registration, etc

· Experienced researcher.

· Excellent written and oral communication skills.

· Excellent project and time management skills.

· Proficient in the use of computers.

· Fluent in English. Additional language skills preferred, but not essential.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Danielle Francois
Danielle Francois
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