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Medical Director – Medical Devices Regulatory Writing



Business Type: Healthcare - Management Consultancy, Medical Communications Agency
Job Type: Medical Writing and Editorial, Regulatory Affairs
Job Level: Experienced (non manager)
Position: Full Time
Salary: £6 figure basic salary, bonus, benefits
Location: United Kingdom
Reference: 891674
Job Details:
Medical Director – Medical Devices Regulatory Writing – Global Scientific and Life Sciences Communications Company – 100% remote role - £6 figure basic salary, bonus, benefits

This is an exciting time to join this global leading, hugely innovative Scientific / Life Sciences Communications company based 100% remotely, wherever you work best. As a senior member of the medical devices team, you will be subject matter expert in writing and reviewing relevant medical device documents and be the SME in liaising with clients and internal stakeholders.

The Company

A global, innovative life sciences communications company is now recruiting for a Medical Director – Medical Devices Regulatory Writing to join their already well-established team. Offering a 100% remote flexible working policy as well as great training and development, this company has a huge interest in developing their employees to a high standard.
·  Global Life Sciences Communications Company
·  Working across multiple therapy areas, multiple class devices
·  Working with some of the biggest names in medical devices
·  Have over 3000 employees over 9 countries
·  Great training and development

The Role

Working on a number of exciting projects, the Medical Director – Medical Devices Regulatory Writing will be responsible for;
·  Function as head of content and subject matter expert on all matters related to medical devices,
·  Expertise in clinical evaluation (specifically reviewing and/or writing clinical evaluation reports and all regulatory requirements under the new EU MDR), regulatory writing/consulting for medical devices in the EU and US
·  Recruit, lead, and develop talent; train new writers on creation of regulatory/clinical deliverables for medical devices (e.g., CEP/CER, PMS plan/PMSR/PSUR, PMCF plan/evaluation reports, Technical Files, CSRs, 510(k)s, IVD documents, regulatory pathways/research)
·  Help lead development of new services and new regions for growing medical device team
·  Accountable for overall content strategy, ensuring medical scientific rigor and delivery of high quality documents to the client
·  Participate in client pitches and in organic and new business development activities
·  Participate in thought leadership activities, including white paper development, facilitating advisory board/panel meetings, speaking at industry conferences, etc.

You

To apply for this role as Medical Director – Medical Devices Regulatory Writing our client is hoping for someone with the following skills and experience
·  Ample Medical Device regulatory service experience
·  Able to act as signatory and medical director for Clinical Evaluation Report (CER) team
·  MD or PhD in a relevant field, with 8-10 years of overall experience in clinical development/regulatory affairs for medical devices
·  Domain expertise in clinical evaluation and post-market surveillance/PMCF and thorough understanding of EU MDR and related guidelines (e.g., MedDEV 2.7/1 Rev 4, MDCG) and
harmonized standards (e.g., ISO 14971)
·  4-5 years of experience in the development of CERs for all classes of medical devices in a
CRO or medical device company setting
·  Strong leadership ability and people management experience

What should you do next?

This Medical Director – Medical Devices Regulatory Writing role is one not to be missed; it encompasses the opportunity to work and lead a highly successful team on some new and exciting products.  To discuss this Medical Director – Medical Devices Regulatory Writing role further or to find out about other Regulatory Affairs / Regulatory Writing jobs I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.


Posted: 06/01/2022 | NPJ Ref: 294564 | NPJ Original URL
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