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A-pharmaconsult recruiting new Regulatory Affairs Project Manager for MDR switching
Grasse, France: – A-pharmaconsult, the consultancy that specializes in services for pharma industries and medical devices, is expanding its Regulatory Affairs capabilities with the recruitment of a new Project Manager.
This will expand A-pharmaconsult’s capabilities to switch Technical Documentation from MDD 93/42 to MDR 2017/745 for CE marked Medical Devices, helping to overcome a widespread regulatory compliance challenge for the medical device sector.
Medical device regulatory expertise
This requires expertise in the drafting, updating, filing and monitoring of technical dossiers for medical devices in accordance with current regulatory and normative requirements, as well as risk analysis and preparation of risk management plan/report for medical devices according to ISO 14971:2019.
The new Project Manager in Regulatory Affairs will be based at the company’s headquarters in Grasse, in France’s Alpes Maritimes department.
Specific skills required
The successful candidate will have a life sciences background, knowledge of European regulations for medical devices, specifically the new MDR 2017/745, fluency in English and previous experience in project management.
A-pharmaconsult SAS is inviting candidates to send their CVs with covering letter to its General Manager, Loic Girot (see Resources).
About A-pharmaconsult SAS
Part of the A-consult group, A-pharmaconsult SAS specializes in regulatory affairs for medicines and medical devices.
A-pharmaconsult services include medical writing, non-clinical writing, technical writing, regulatory strategy, and quality systems. These offerings include preparation of marketing authorization dossiers for drugs, technical documentation for medical devices, regulatory consultancy and documentation for quality management systems (GMP, GDP, ISO 13485 & ISO22716).
From both its Danish and French origins, this consulting company has remained deeply focused on helping pharmaceutical, medical devices and cosmetics businesses operate in an increasingly complex regulatory environment, underpinned by core values of expertise, respect, and confidence.
A-pharmaconsult has built long term partnerships across a broad range of different companies with a “tailor made” offering to suit every size of company and specific needs,
For more information, visit www.a-consult.com