Regulatory Affairs Specialist
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Intl. Sr. Business Partner TA, EMEA & APAC @ CooperSurgical
At CooperSurgical we are currently looking to recruit a Regulatory Affairs Specialist for an 18-month contract to cover maternity leave. You will be part of the global regulatory team, but primarily work with the UK RA based team. For this position you can be based in UK or EMEA and have an opportunity to work from home, remotely. This role will be reporting to the RA Manager based in UK.
Position
In the role of RA Specialist, you will be responsible for submissions globally but primary focusing on MEA and LATAM. You have strong experience with global product registration and re-registration and adept at liaising with the right people to collect and gather the relevant documentation and files. You will be responsible for completing annual renewals and following up on deadlines and tasks, to meet submission timelines. Preferable you have worked with single use sterilized products and electrical, electronic devices, and be familiar with the appropriate standards and regulations.
As a person you thrive in a dynamic and busy environment which provides you with an opportunity to use your planning and prioritization skills to meet deadlines and progress registration projects. You will work closely together with other RA professionals and cross functional stakeholders in this international organization.
The position as RA Specialist is vital for the success and growth of CooperSurgical.
Your key responsibilities
- Lead regulatory activities, reviewing, maintaining, and submitting files and legalized documentation
- Facilitate collection of data for international registrations
- Monitor for any change in META & LATAM medical device regulations
- Liaise with stakeholders globally
Your Qualifications
- MSc in relevant field Engineer, Bio Science, Technical or alike
- + 2-3 years of experience from a similar role -preferable
- Structured and systematic work ethic
- Strong communication and problem-solving skills
- Proficient level in MS office
- Fluent English (spoken and written) is mandatory
- A can-do attitude and proactive approach
We can offer a challenging position within a dynamic, globally leading, high growth company. You will work together with competent colleagues in a positive environment, that welcomes people of all views and backgrounds and provides countless ways to grow and develop.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Administrative, Research, and OtherIndustries
Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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#J-18808-Ljbffr- Location:
- United Kingdom
- Salary:
- £60,000 - £80,000
- Job Type:
- FullTime
- Category:
- Management & Operations