Medical Device Regulatory Label Specialist
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Job Description
Biocomposites, Ltd. is an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue. Based in Keele in Staffordshire, UK, it has global operations across Europe, USA, Canada, Argentina, China and India, and helps more than 1 million patients worldwide every year!
Location & Working pattern
Primary working location: Keele office (IC4/5) on-site, min of 4 days per week expected with additional days according to business needs (e.g. audits requiring on-site attendance, submission deadlines)
Responsibilities
* Accountable for the creation and maintenance of product specific documents for global products to ensure compliance with relevant FDA, MDR, ISO and other global regulations.
* Ensures product labels and IFUs are accurate, compliant and maintained globally.
* Lead the creation and implementation of electronic IFUs for Biocomposites products.
* Conducts standards assessments when new standards/regulations or changes to existing standards/regulations are published. Responsible for assessing impact to current product labelling and executing change requests to facilitate labelling updates to meet requirements.
* Leads meetings and discussions with cross-functional teams (e.g. Regulatory Affairs, Operations, Clinical, R&D, Quality, Legal, Commercial, Marketing) to prepare, populate and drive alignment of labelling-specific content to meet requirements.
* Leads and tracks to resolution any issues encountered during product specific document development and approval.
* Implements procedures to document the process for development of product specific documentation, from the creation of labelling requirements specifications to final product specific documents used in R&D, clinical trial and commercial products.
* Monitors, evaluates and recommends improvements to labelling process, systems, tools and/or procedures.
* Participation in internal and external audits.
* Line management and/or mentorship of junior team members, as required.
* Acts as delegate for label activities falling under the remit of the Regulatory Affairs Project Manager, when needed.
Required experience:
* Bachelor’s Degree in a life science or equivalent
* Minimum 2 years’ relevant medical device and regulatory experience
* Applied knowledge of European (MDR) and US FDA labelling requirements
* Applied knowledge of medical device product labelling processes for review and obtaining regulatory approvals.
* Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.
* Ability to critically and efficiently review detailed information to support a label or IFU update.
* Demonstrated ability in analytical reasoning and critical thinking skills
* Ability to both contribute and lead in a team environment
* Strong oral and written communication skills
* Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
* Experience in working with graphic design software such as Adobe Creative Cloud, In-Design, Bartender or equivalent software systems
* Applied experience of labelling requirements in countries outside of the EU and USA.
* Knowledge of medical device regulatory affairs throughout the product lifecycle including Development, Commercialisation, and Operations
What do we offer?
Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.
We grow talent. At Biocomposites we create opportunities to thrive and grow.
One Biocomposites - team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.
If you are interested please forward your CV and cover letter stating the position you wish to apply for to careers@biocomposites.com
Benefits:
* Company events
* Company pension
* Employee discount
* Free or subsidised travel
* Free parking
Seniority level: Entry level
Employment type: Full-time
Job function: Design, Art/Creative, and Information Technology
Industries: Industrial Machinery Manufacturing
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