Regulatory Affairs Specialist
3 days ago
**Here at Hologic it is our purpose to enable healthier lives everywhere, every day.**
**We are driven by our passion to become the global champion for women’s health.**
**We achieve this by fulfilling our promise to bring The Science of Sure to life**.
We are looking for a skilled **Regulatory Affairs Specialist** to join our Diagnostics Division in Manchester. As the Regulatory Affairs Specialist, you will assist in the management of all regulatory activities globally.
**What to Expect**:
- You will be able to interpret and explain regulatory requirements and standards for IVDs and medical device products to cross-functional stakeholders.
- Provide guidance on global requirements for new and existing products, keeping informed of new and revised regulations.
- Prepare and manage internal documentation to enable continuous improvement.
- Recommend labeling, manufacturing, analytical and clinical study plans for regulatory compliance.
- Review validation, clinical/R&D protocols and reports to be included in regulatory submissions.
- Develop regulatory strategies for domestic and international markets.
- Write, edit and/publish submission documents by using or creating regulatory templates.
- Provide regulatory guidance on product design and development plans: labeling, preclinical, and clinical studies.
- Assess manufacturing process, design, and labeling changes for regulatory reporting impact.
- Work with regulatory agencies to clearly present submissions strategies in support of predictable and timely clearance and approvals.
- Liaise with product development teams and regulatory authorities throughout the product lifecycle.
- Identify and communicate potential risks of regulatory pathways to the stakeholders. Work on mitigation plans to reduce regulatory risk
- Provide recommendations for compliant advertising/promotional materials
**What We Expect**
- Technical knowledge within the regulatory, quality or manufacturing arena
- An understanding of IVD regulations in the US and international markets
- An understanding of the product life cycle process, design, control or risk management
- Effective technical writing and verbal communication skills
- Enthusiasm, and a demonstrated learning agility
- Involvement - you must be a team player, and also comfortable working to your own initiative.
- Willing to be in our Manchester office for ongoing training, and teams activities
**So why join Hologic?**
We are committed to making Hologic the 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.
Our talent partners can discuss our salary offering and bonus scheme with you. We also have a range of incredible benefits to support you through your working and personal life, these range from a private pension plan, private healthcare, enhanced maternity pay and many more.
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