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Lead Regulatory Specialist

Employer
i-Pharm Consulting
Location
Homeworking
Salary
USD120000.00 - USD145000.00 per annum + healthcare, unlimited PTO
Start date
23 May 2023
Closing date
20 Jun 2023

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Discipline
Regulatory Affairs, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

A consulting firm in the IVD and Diagnostics industry is looking for a Regulatory Affairs professional to come onto their small, close, remote team

The company has been responsible for the design, development, and management of molecular diagnostic systems, molecular assays, start-ups, and build-ups of several companies. They pride themselves on developing a vast network of in-house and in-network consultants that collectively can solve any problem. Projects in this IVD role will include reagent and instrument device design, development, and regulatory agency submissions

Day-to-day responsibilities will include:

  • Regulatory review of promotional marketing materials, press releases, labelling, etc. for clients to ensure that global regulatory agency requirements are met

  • Participate in the development of clinical trial protocols for clients

  • Liaise and negotiate with global regulatory authorities on behalf of clients

  • Provide advice about regulations to clients for new and/or changed products

  • Coordinate successful submissions and approval of all applications

  • Assist clients in creating technical files, risk management plans and reports, and clinical evaluations

  • Review all global regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards

  • Monitor FDA communications, including Town Hall Meetings, emerging trends regarding industry regulations to determine potential impacts on clients

    • Education and Experience:

  • BA/BS in life sciences or Clinical Laboratory Scientist

  • Must have a minimum of 3-5 years Regulatory Affairs experience in IVD, CDx or Medical Devices

  • Experience in 510(k) full process responsibility

  • Experience as an RA representative on core teams providing regulatory guidance and RA strategies

  • Experience in the balance and application of regulatory requirements and ability to explain the pros and cons to clients.

  • Direct and positive experience in communicating with Regulatory Authorities.

    • Benefits include:

  • Full Medical for all full-time employees and 50% for all dependants

  • 401K plan with 5% match

  • Flexible unlimited vacation

  • Potential for great growth, including on-the-job training and continuing education opportunities

    • Company

    i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

    We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

    Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

    With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

    For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

    As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

    We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

     

    Company info
    Website
    Telephone
    +44 (0) 20 3189 2299
    Location
    52 Bedford Row
     London
    England
    WC1R 4LR
    United Kingdom
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