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- Tasks: Join our team to manage regulatory activities for innovative medical products.
- Company: Werfen is a leading company in the medical device industry, focused on improving patient outcomes.
- Benefits: Enjoy flexible working options and opportunities for professional growth.
- Why this job: Be part of a dynamic team making a real impact in healthcare compliance and innovation.
- Qualifications: Bachelor's degree in life sciences or engineering; 2 years in the Medical Device Industry required.
- Other info: International travel may be necessary; experience with SAP is a plus.
The predicted salary is between 36000 - 60000 £ per year.
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Regulatory Affairs Specialist II, Bedford
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Client:
Werfen
Location:
Bedford, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
79d2bff98637
Job Views:
4
Posted:
29.06.2025
Expiry Date:
13.08.2025
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Job Description:
Overview
Position Summary:
Responsible for domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain domestic and international compliance.
Responsibilities
Key Accountabilities
Essential Functions:
Responsible to participate on design and risk management teams in the Hemostasis group as the Regulatory representative and provide guidance on domestic and international requirements, including:
- Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input.
- Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output.
- Prepare new product registration packages and technical files (e.g. CE Mark, ks, Canadian licenses).
- Provide support materials for Milan Regulatory for other country registrations.
- Assist with product renewal packages to maintain country registrations.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current scientific and regulatory standards.
- Responsible for maintenance of Regulatory Database in SAP.
- Responsible to review marketing and sign promotional materials for signature by management (as appropriate).
- Responsible to review and sign labeling and Change Orders (as appropriate).
- Educate and train Werfen personnel on domestic and international country registration and labeling requirements to ensure that during product development, their requirements are understood and incorporated.
- Other assignments related to RA/QA to support Werfen requirements and priorities
Budget Managed (if applicable):
- N/A
Internal Networking/Key Relationships:
- To be determined based on department needs
Skills & Capabilities:
- Requires superior communication skills (verbal and written)
- Proficiency with standard software (Word, Excel, PowerPoint, Adobe Acrobat etc.)
- Hands on experience working in a regulated environemnt following QMS systems.
- Previous experience and familiary with In vitro Diagnostics, software in medical device strongly preferred.
- Experience with SAP is a plus.
Qualifications
Minimum Knowledge & Experience Required for the Position:
- Requires a Bachelor degree, preferably in life sciences or engineering familiarity with ISO and preferred.
- Two years minimum experience in the Medical Device Industry or other highly regulated environment.
International Mobility: Required:
- No
Travel Requirements:
- Must be available to travel domestically and internationally as needed.
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Regulatory Affairs Specialist II employer: Werfen
Contact Detail:
Werfen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist II
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks relevant to the medical device industry, especially those pertaining to in vitro diagnostics. This knowledge will not only help you during interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals already working in regulatory affairs within the medical device sector. Attend industry conferences or webinars to make connections and gain insights into current trends and challenges in the field.
✨Tip Number 3
Prepare to discuss your hands-on experience with Quality Management Systems (QMS) and any familiarity with SAP during interviews. Be ready to provide examples of how you've navigated regulatory requirements in past roles.
✨Tip Number 4
Showcase your communication skills by preparing to explain complex regulatory concepts in simple terms. This is crucial as you'll need to educate and train others on compliance requirements, so practice articulating these ideas clearly.
We think you need these skills to ace Regulatory Affairs Specialist II
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Affairs Specialist II position. Tailor your application to highlight relevant experience in regulatory compliance and product registration.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in the Medical Device Industry or other regulated environments. Mention specific projects where you contributed to regulatory submissions or compliance activities.
Showcase Communication Skills: Since the role requires superior communication skills, provide examples in your application that demonstrate your ability to communicate complex regulatory information clearly and effectively, both verbally and in writing.
Tailor Your Documents: Customise your CV and cover letter for this specific role. Use keywords from the job description, such as 'regulatory plans', 'technical files', and 'compliance', to ensure your application stands out to recruiters.
How to prepare for a job interview at Werfen
✨Know Your Regulatory Frameworks
Familiarise yourself with the specific regulatory requirements relevant to the medical device industry, especially those pertaining to in vitro diagnostics. Be prepared to discuss how these regulations impact product development and compliance.
✨Demonstrate Communication Skills
Since the role requires superior verbal and written communication skills, practice articulating your thoughts clearly. Prepare examples of how you've effectively communicated complex regulatory information in previous roles.
✨Showcase Technical Proficiency
Be ready to discuss your experience with software tools like SAP, Word, Excel, and Adobe Acrobat. Highlight any specific projects where you utilised these tools to manage regulatory documentation or data.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in a regulated environment. Think of scenarios where you had to navigate regulatory challenges and be ready to explain your approach and the outcomes.
