Regulatory EMEA Lead - Devices
ProClinical is advertising a vacancy for a Regulatory Affairs Lead, EMEA with a leading electronic manufacturing company that takes on real-impact and fast-moving fields, such as healthcare. This exciting company is seeking a talented individual to join their team in Switzerland.
- Providing local support and leadership for registration and licensing requirements as they apply to products and services of the company, both domestically and internationally, as well as facility licensing activities pertinent to EMEA.
- Reviewing labelling for compliance to local regulatory requirements, including all communications to trade publications, news media releases, sales presentations, and technical bulletins specific to the region.
- Ensuring international vigilance processes and management for Product Surveillance (distributor, direct sales, and service) are relevant, effective, and maintained.
- Collaborating with and provide oversight to local RA Strategists on the preparation of submissions to local RA health authorities, as well as formulating and implementing regulatory strategies to assure timely global commercialisation of products in compliance with applicable regulations and standards.
- Planning, creating, and maintaining the regulatory dossiers (Technical Documentation) in line with changing national and international regulatory demands.
- Representing and auctioning the associated regulatory responsibilities in front of the Competent Authorities, Notified Bodies, and other regulatory authorities or associations.
- Developing and implementing regional regulatory strategies and processes to support the timely registration of, new products, major changes and life cycle management with a thorough deployment of new or updated legislations.
- Enabling regulatory leadership and partnership necessary to facilitate speed-to-market and to achieve regulatory timelines and milestones.
- Ensuring compliance by executing against the regulatory plan, reviewing all relevant materials, and identifying potential regulatory approval risks.
- Managing and overseeing the generation of documentation for submission to regulatory agencies to secure product approvals.
- Representing the organization in local or regional standard committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization.
Skills and Requirements:
- At least a Bachelor's Degree from an accredited college or university, in science, biomedical engineering, medical/scientific writing, public health administration, or similar. An Advanced Degree, such as an MS or PhD is preferred.
- At least 7 years of business experience, and at least 5 working in Regulatory Affairs.
- Thorough knowledge of relevant medical device laws, regulations, guidelines and standards, in particular, but not limited to, th e European Medical Device Directive/Regulation as well as FDA 21 CRF Part 820, and implements, via suitable processes.
- Regulatory Affairs Certification (RAC) and/or Certification in Medical Device Regulatory Affairs preferred.
- A successful track record of supporting project teams and preparing submissions for Class II and Class III medical devices.
- A thorough understanding of EMEA regional regulatory requirements and demonstrated successful implementation of the regulatory requirements through product lifecycle.
- Excellent interpersonal skills, including communication, presentation, persuasion, and leadership.
- Excellent business English, orally and in writing.
- Demonstrable experience interacting with Health Care Professionals, patients, and consumers to complete and close complaint investigations.
- Demonstrable experience with complaint management software systems and databases.
- A basic understanding of statistical tools.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alex Czuprynski on + 44 203 869 2329 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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