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- Tasks: Manage pre-market regulatory activities and ensure compliance with global regulations.
- Company: Leading company in the medical device industry focused on innovation.
- Benefits: Attractive salary, comprehensive health benefits, and opportunities for professional growth.
- Why this job: Play a crucial role in shaping healthcare products that impact lives.
- Qualifications: Experience in regulatory affairs and strong communication skills required.
- Other info: Join a dynamic team dedicated to improving patient outcomes.
The predicted salary is between 54000 - 84000 £ per year.
Responsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) /46, as well as other country regulatory agencies.
Represents regulatory on design teams, prepares regulatory plans, authors US FDA (k)s, Health Canada license and EU Notified Body submissions and interfaces with these agencies through submission completion.
Acts as reviewer on product labeling, including commercial materials such as brochures and presentations, for regulatory compliance.
Senior Principal Regulatory Affairs Specialist in Bedford employer: Werfen
Contact Detail:
Werfen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Principal Regulatory Affairs Specialist in Bedford
✨Tip Number 1
Network like a pro! Reach out to professionals in regulatory affairs on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that Senior Principal Regulatory Affairs Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of US FDA, Health Canada, and EU IVD Regulations. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise during the interview.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest checking out our website for tailored job listings that fit your skills in regulatory affairs. It’s all about finding the right match!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We believe this small gesture can help keep you top of mind for hiring managers.
We think you need these skills to ace Senior Principal Regulatory Affairs Specialist in Bedford
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Principal Regulatory Affairs Specialist role. Highlight your experience with US FDA, Health Canada, and EU regulations, as this will show us you understand the key requirements of the position.
Showcase Your Achievements: When detailing your past roles, focus on specific achievements related to regulatory submissions and compliance. We love to see quantifiable results, so if you've successfully managed submissions or improved processes, let us know!
Be Clear and Concise: Regulatory affairs can be complex, so make sure your application is straightforward and easy to read. Use clear language and avoid jargon where possible. This will help us quickly grasp your qualifications and fit for the role.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows us you’re keen to join the StudySmarter team!
How to prepare for a job interview at Werfen
✨Know Your Regulations
Make sure you brush up on the latest US FDA, Health Canada, and EU IVD Regulations. Being able to discuss specific regulations and how they apply to the role will show your expertise and commitment to compliance.
✨Prepare Your Success Stories
Think of examples from your past experiences where you've successfully managed regulatory submissions or navigated complex compliance issues. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly.
✨Familiarise Yourself with the Company
Research the company’s products and their regulatory history. Understanding their market position and challenges will help you tailor your responses and demonstrate your genuine interest in the role.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory strategies and future projects. This not only shows your enthusiasm but also helps you gauge if the company aligns with your career goals.
