- 经验
- 任何
- 薪水
- GBP 23 – GBP 23 / hour
- 职位空缺
- 1
- 发布
- 4小时前
- Work mode
- 杂交种
- 学历
- Degree in Regulatory Affairs, Life Sciences, or related discipline (or equivalent experience)
- Eligibility
- Professionals with regulatory affairs experience in regulated industries such as medical devices, pharmaceuticals, or life sciences, and candidates with a degree in Regulatory Affairs, Life Sciences, or a related discipline, or equivalent experience, can apply.
- Resume
- Required to apply
Where you'll work
职位描述
Role overview
We are looking for a Regulatory Operations Specialist to support product and solution development within a tightly regulated environment. The role is focused on helping ensure compliance with international regulatory requirements and contributing to the success of product submissions.
Location and contract
- Bracknell (Jealott’s Hill)
- Hybrid working pattern with on-site presence expected 2 to 3 times per week
- Pay rate: £23 per hour
- Temporary contract options available for 6 months or 12 months
Key responsibilities
- Support cross-functional development teams with guidance on regulatory standards, expectations, and strategy.
- Plan, prepare, and coordinate regulatory submissions, making sure all documents are complete, accurate, and compliant.
- Review development quality documentation to confirm it is ready for submission.
- Coordinate testing activities needed to support regulatory approvals.
- Assess and approve product labels and marketing content to ensure they meet regulatory requirements.
- Maintain existing regulatory filings and licences, including updates and change-control activities.
- Assist with regulatory planning for new product launches and product modifications, including CE marking and risk assessment work.
- Work closely with product and project teams to align regulatory direction with business goals.
Requirements
- Previous experience in Regulatory Affairs within a regulated sector such as medical devices, pharmaceuticals, or life sciences.
- Good knowledge of regulatory submissions and compliance procedures.
- Experience reviewing product labelling, marketing materials, and regulatory documentation.
- Ability to collaborate across functions and manage several stakeholders at once.
- A degree in Regulatory Affairs, Life Sciences, or a related field, or equivalent practical experience.
- Exposure to regulated environments through academic training and/or industry experience.
Additional information
- Immediate start available.
- Opportunity to contribute to innovative product development programmes.
- Flexible contract lengths of 6 or 12 months.