Regulatory Affairs Specialist Job
We are seeking a skilled Regulatory Affairs Specialist to ensure compliance with regulatory standards and manage day-to-day regulatory activities.
About the Role
This role involves working closely with the QA Manager to ensure the effectiveness of the QMS to regulations, managing day-to-day regulatory activities, and handling multiple projects related to product and compliance enhancements.
Main Responsibilities
* Ensure compliance with regulatory standards and maintain effective Quality Management Systems (QMS).
* Work closely with the QA Manager to ensure notified body audits and other audits are handled efficiently.
* Manage multiple projects related to product and compliance enhancements.
* Migrate from MDD to MDR within the organisation.
* Support the team in ensuring product manufacture and testing meets the requirements of CE mark and FDA submissions.
* Work with suppliers to ensure products' process validations and risk management files are compliant with regulatory submissions.
* Provide strategic regulatory insight to team members regarding product development plans.
* Work with the Commercial Team / Distributors to ensure country-specific registration activities are understood and addressed.
* Log customer complaints and adverse events, coordinate investigations between complainants and contract manufacturing sites, and address initiatives to test, change and improve the products as required.
* Monitor global regulatory trends and requirements impacting the development and commercialization of products.
* Evaluate manufacturing and labelling changes, and promotional materials for regulatory impact.
* Maintain awareness of global regulatory legislation and assess its impact on business and product development programs.
* Keep abreast of changes in domestic and international regulations and guidelines.
Requirements
* Bachelor's degree in engineering or science with a minimum of 4 years of experience in a medical device company.
* Regulatory certifications in MDR desirable.
* A minimum of 4 years of experience in the medical device industry.
* Thorough understanding and knowledge of ISO 13485, ISO 14971, MDD & MDR.
* Proven track record with the ability to successfully manage projects to deadlines.
* Experience working directly with regulatory agencies.
* Strong ability to manage critical projects as part of an interdisciplinary team.
* Excellent problem-solving and communication skills.
* Self-motivated, highly organised, and detail-oriented.
* Excellent oral and written communication skills.