CH - Regulatory Affairs Specialist - Senior
A globally renowned pharmaceutical company is seeking to recruit a Regulatory Affairs Specialist - Senior to their office in Switzerland. The organisation works across a range of industries, from medical devices to pharmaceutical and consumer goods, and operates in over 60 countries. This position offers an exciting opportunity to work with a prestigious and historic pharmaceutical establishment and provide real regulatory expertise.
- Ensuring that the company's products comply with the regulations set up by government agencies.
- Advising engineering and manufacturing on regulatory requirements.
- Assisting with product reviews and process documentation for assigned projects to ensure compliance with change control requirements and aid in determining if regulatory submissions are required.
- Creating, reviewing, and maintaining regulatory related technical documentation.
- Capturing and verifying regulatory product characteristics to support logistic and supply chain efforts on a global scale.
- Working with cross-functional teams to obtain relevant information and subsequently reviewing submission content as needed; assisting in reviewing international product technical documents, marketing, and labeling materials.
- Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations.
- Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals.
- Providing progress of work-plans and the status of key project deliverables.
- Following the quality standards and regulatory requirements.
- Knowing and following all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times.
- Resolving complex issues as they arise.
Skills and Requirements:
- Bachelor's (minimum 3 years of experience) or Masters (minimum 2 years of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.
- Familiarity with Technical Documentation structure according to STED required.
- 3-5 years of experience in European Medical device industry, especially with regulatory, quality, or engineering.
- Strong knowledge of ISO 13485 and ISO 9001, and QSR.
- Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation.
- MEDDEV guidance documents applicable to Medical Devices products and processes.
- Reasonable knowledge of o FDA requirements.
- Registration requirements in further global markets would be an asset.
- Strong understanding of Risk Management process, label and labeling, and change management is desired.
- International experience preferred.
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 contact Manon Luflade at +44 2038540586 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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