One of my key clients are currently seeking an experienced Regulatory Affairs Specialist to join their team on an initial 6 month hourly rate contract. The company are a globally recognised medical device company, specialising in the manufacture of wound care products and therapies. The company is a family owned company, ensuring it is a great place to work, with exposure to cross functional teams.
Your role as a Regulatory Affairs Specialist will be to aid in the development of regulatory strategies, perform activities associates with obtaining and maintaining regulatory approval in target markets.
Role: Regulatory Affairs Specialist
Contract: An initial 6 month hourly rate contract
- Maintain an excellent understanding of global medical device regulations for specific areas in accordance with ISO13485:2016 standards.
- Ensure a thorough understanding of products as they are assigned.
- Plan and prepare regulatory submissions for specific target markets for new products, product changes and re registrations as required.
- Provide support to currently marketed products as needed including input on change requests etc.
- Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations including ISO13485:2016.
- Create technical file submissions to collate information for regulatory submissions.
- Obtain information, create reports, develop summary reports to various countries.
- Change controls for regulatory requirements.
- 3 - 5 years experience within a highly regulated environments.
- Experience in Regulatory Submissions and CE marking is essential.
- Excellent organisational skills.
- Ability to work as an individual, as well as part of a team.
- Experience within the medical device industry is desirable.
- Degree in Science / Engineering discipline.
No CV ready? Not sure yet? Feel free to contact me for further details.
This is an excellent opportunity to work as part of a global medical device company, alongside an innovative, and enthusiastic Regulatory team.
To find out more about Real please visit www.realstaffing.com
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