I’m partnered with a Large medical technology company based in Reading. They are looking for an Regulatory Affairs Specialist with the following skills to join their team for a full-time employment
* Manage independently multiple registration projects with direction/support from a supervisor. Interacts with a manager as required on activities, issues, or milestones. Inspires effective unit dynamics and imparts a sense of commitment to unit goals. Encourages and empowers others to achieve outcomes.
* Review and approve labelling /promotional/advertising materials, change order assessment and approval, and other documents to ensure compliance with the appropriate regulations.
* Formulate short-term planning for individual deliverables and participates in long term planning within the unit. Influences content in the functional scorecard, including the development and definition of measurable goals and objectives consistent with business and operating plans.
* Licensing and approvals requirements and communicate these requirements to the appropriate teams. * Create regulatory strategies, by reviewing and providing input about changes to ensure compliance to the appropriate regulations.
* Minimum of 3 years of pharmaceutical regulatory affairs experience, with medical device or combination products experienced desired.
* Must have previous experience with global submissions
* Experience working with cross-functional teams
* Preferred education/experience areas include health care, physical, biological, and regulatory sciences, clinical, engineering, potentially coupled with advanced degrees (MS, MBA, PhD, etc.)
Offering: Permanent position in Reading
If this role sounds interesting, please get in touch via email or phone. Send your CV to:
This role is urgent, and with the high volume of applicants, we may not be able to get in touch with everyone. Interviews will happen as and when a great candidate gets in touch.
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