Regulatory Analyst - Cork
Mary Tilston is recruiting for a Regulatory Restrictions/Product Discontinuation Analyst (Devices) to join a well known medical device company that manufacture a prestigious range of neuro and orthopaedic products. This position is a contract role for the duration of 12 months based in Cork, Ireland
The main purpose of your role will be to:
- Perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information.
- Know, understand, incorporate and comply with all applicable laws and regulations relating to company business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- Coordinate related regulatory submissions such as EU Design Dossiers and Technical Files, IDE's, PMA's and 510(k)s, including those of a complex or strategic nature, and coordinate resources for larger regulatory submissions.
Further responsibilities will include:
- May act as an operational expert rotating to new projects to provide technical expertise and training in regulatory submissions and regulatory strategy.
- Providing expertise in foreign regulatory requirements.
- Managing and/or coordinating regulatory submissions and files, including 510(k)s, PMAs, PMA supplement, IDE, Minor Modification, EU technical file, design dossier, and technical file revision.
- Assisting in the development of best practices for Regulatory Affairs processes
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or above in Life Science or equivalent.
- Must have significant experience within Regulatory Affairs
- Must have experience of Medical Devices within Regulatory Affairs.
This is an excellent opportunity to join one of the leading global pharmaceutical companies with great potential and opportunities to develop your career.
For more information or to apply for this position, please contact Mary Tilston on 01438 768717 or email firstname.lastname@example.org. Alternatively click on the link below to apply online.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37058 in all correspondence.