CMC Regulatory Expert
Opportuntiy to work for a gorwing medical devices company
Autonomous working environment
About Our Client
Class 2 Medical Devices Manufacturer, based in Slough, looking to expand their Regulatory team to include a CMC expert. They manufacture Ophthalmic Products for global distribution.
The key responsibilities are:
- Gap analysis, authoring, compiling and reviewing of dossier and STED for both medicinal product and medical devices.
- Artwork management on medical devices and pharmaceutical products.
- Research and advise on device classification, Pharmaceutical product regulatory pathways and strategies.
- Prepare and submit EU market technical files and other international regulatory pre-market submissions (510(k)s, Canada MDLs); US OTC Monograph submission, EU and global regulatory agencies.
- Interact and negotiate directly with regulatory authorities and notified bodies, assist in addressing and responding to deficiencies of product submissions identified by regulatory bodies.
- Assist in drafting/updating Post Market Surveillance reports.
- Author STED components, CERs, risk management, labelling to support CE marking.
- Support various audits and continuous improvement activities.
The Successful Applicant
The successful candidate will:
- Have over 5 years' experience in CMC Regulatory
- Experience with Class II devices is desirable
- End to end regulatory life cycle management experience within Pharmaceutical product and medical devices.
- Knowledge of US and international medical device regulatory requirements, procedures, regulations and interpretation as it relates to pharmaceutical ophthalmic products and medical devices.
- Experience developing strategies for Product Registrations in the EU and New territories, ensure that all required documentation is in place on time, identify and track critical path activities in collaboration with Local representatives and distributors as appropriate.
- Experience determining regulatory pathway for registration of new drug formulations in new territories is desirable but not mandatory
What's on Offer
£40,000-£50,000 basic salary