Regulatory Affairs Manager (Medical devices), Maidenhead

Regulatory Affairs Manager (Medical devices) This is a contract role on a 9 Month Contract. As Regulatory Affairs Manager, you will be Responsible for developing and implementing innovative global regulatory strategies for product development and approval within the Medical Device Industry. Responsible for defining strategies for obtaining and updating post-approval compliance. Ownership of regulatory documents, submissions, and compliance issues. Represent the company with contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. Some direct report management may be required. As Regulatory Affairs Manager, you will be accountable for: The successful development and implementation of regulatory strategies for new registration submissions including post-approval compliance for assigned portfolio in region. Provide strategic guidance and regulatory leadership at project team meetings as well as represent the Global Emerging Markets strategy for assigned products in region. Identifying regulatory risks associated with the execution of regulatory strategies in assigned region. Define strategies to mitigate risks. Keep abreast of changes in regional legislation. Responsible for coordinating the preparation of the regulatory submissions including responses to questions from the Health Authorities o Lead preparation and represent the company at Health Authority meetings. Highlight key issues that may impact the execution of regulatory strategy across territories. Building and maintain effective relationships with both internal as well as external stake holders as well as preparing and delivering effective presentations for external and internal audiences. To be considered for the role of Regulatory Affairs Manager (Medical devices) You will: Demonstrate strong organizational skills, strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, drug safety, scientific, and manufacturing staff. Qualifications required for this position are: Minimum 6-8 years pharmaceutical/biotechnology industry experience (including 5 years + of Regulatory Affairs experience). Education: BA/BS/University degree required, Life/Health Sciences preferred. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application. Candidates must be eligible to live and work in the UK. For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business