About The Role
Bespak are looking for a Regulatory Specialist for the Kings Lynn site (PE30 2JJ). The salary range for this permanent role is between £50k to £59k, plus a discretionary annual bonus. Our generous benefits package includes 28 days leave plus bank holidays, 8% company pension contribution to employees’ 3%, onsite parking, and medical/dental/health/life assurance.
Working Pattern
Mon to Fri, 7.5 hours per day plus a 30 minute lunch break, between 8am and 5pm (8am to 4pm or 9am to 5pm). In this hybrid role you would need to attend the King’s Lynn (PE30 2JJ) or Holmes Chapel (CW4 8BE) office at least 4 days each month; we are happy to discuss how this works best for you.
Responsibilities
* Deliver high quality and compliant documents to customers.
* Provide technical insight into regulations for various projects.
* Support technical aspects of drug device product development.
* Review and approve technical files and regulatory submissions.
* Act as an escalation point for complex regulatory questions.
* Mentor less experienced team members through training initiatives.
Preferred Key Skills and Experience
* Extensive regulatory experience in pharmaceutical sectors (Medical Devices).
* Degree level education in a relevant scientific subject.
* Expertise in medical device standards.
* Proven ability to manage multiple projects and priorities.
* Professional communication skills for internal and external stakeholders.
* Proficient with EU and US regulatory filing procedures (Medical Devices).
Benefits
* 28 days holiday + bank holidays
* 8% employer contribution added to employee’s 3%
* Private medical insurance
* Private dental insurance
* Permanent health insurance
* Group life assurance
* Well-being programme
* Employee Retail Discount Platform
* Recognition awards
* Free parking
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