Regulatory Affairs Specialist

2 weeks ago

Manchester, United Kingdom Hologic Full time

**Regulatory Affair Specialist**

**Manchester (M23)**

Discover a career with real meaning.

One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.

As a Regulatory Affairs Specialist, you will be responsible for providing regulatory support for IVD medical device development activities, as well as pertinent regulatory activities in EU and other territories. This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting.

**What you can expect**:

- Prepare, compile, and publish electronic pre-market and post-market regulatory submissions by e.g., compiling technical files and design dossiers.
- Support development of international regulatory strategies
- Develop and execute submission strategies for assigned projects including monitoring of progress on key project deliverables and providing status updates on regular basis.
- Interact with business partners to support international submissions for IVD medical devices (Asia PAC, UK, Canada, Middle East etc.).
- Review new product design protocols related to e.g., verification and validation and risk assessment.
- Review of product labeling, literature and marketing material for accuracy, consistency and regulatory compliance.

**What we expect**:

- Demonstratable experience in a similar role is essential.
- Fluent in English, both written and verbal.
- Strong influence and communication skills,

**So why join?**

We are committed to making our company where top talent comes to grow.

For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.We offer a competitive salary and an annual bonus scheme, one of our talent partners can discuss this in more detail with you.

LI-SA1

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