Regulatory Affairs Specialist
5 months ago
As Regulatory Affairs Specialist responsibilities include:
- Collaborate closely with the Regulatory Affairs Manager to develop and maintain technical files and submissions for global regulators.
- Utilise your regulatory expertise to support the development of regulatory strategies for product submissions.
- Analyse routes to market and provide relevant information to senior regulatory team members.
- Assist in the development and maintenance of regulatory processes to meet pre and post-launch obligations.
- Maintain accurate records related to regulatory procedures and filings.
- Foster collaborative relationships across departments and support project teams effectively.
- Contribute to the development and training of project teams in regulatory affairs.
Qualifications/Experience required:
- Two or more years of experience in regulatory affairs within the diagnostics or medical devices industry
- Strong knowledge of FDA, EU regulations, ISO 13485, and ISO 14971
- Excellent communication and writing skills
- Strong team-working, analytical, and problem-solving skills
- Ability to make decisions and escalate when necessary
Benefits: Outstanding benefits including an attractive bonus, generous pension contributions, private healthcare, and a competitive salary.
Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency
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