The successful Senior Regulatory Affairs Specialist will have a solid and in-depth knowledge of global medical device regulations, standards and guidance documents, as well as regulatory compliance requirements. This position will also be responsible for the preparation and submission of documentation for regulatory registration of the company’s products and will serve as a role model in the areas of regulatory, leadership, teamwork, customer focus and continuous improvement.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Perform as regulatory representative on core product development teams and communicate regulatory requirements and impact of regulations to the development teams. Provide regulatory guidance and expertise.
- Prepare robust regulatory applications or technical file documentation to achieve departmental and organizational objectives and supports EU MDR transition activities.
- Identify the need for bench, animal, biocompatibility and clinical data necessary to obtain regulatory approvals with emphasis on US, European CE mark under MDR, Japan, China, Canada and Australia.
- Review change orders and assesses worldwide regulatory impact of manufacturing or product changes. Review and approve labeling changes to ensure compliance with regulatory requirements.
- Review technical documentation in order to comply with regulatory/MDR requirements. Prepare and maintain technical files and design dossiers in compliance with MDR. Additionally, may prepare and submit US PMA supplements.
- Create and conduct risk assessments for specific regulatory requirements i.e. ISO 15223, 10993-1, etc.
- Interface directly with regulatory agencies and notified bodies (primarily in the US and EU).
- Support the product release process by reviewing and approving requests for product release.
- Develop and maintain Regulatory Affairs procedures.
- Provide mentoring and leadership to Regulatory Specialist I and team members
LOCATION: Theragenics, Buford, GA
DEPARTMENT: Quality and Regulatory Systems
REPORTS TO: Director of Quality and Regulatory Systems
- Bachelor’s Degree Required.
- RAPS Certification Preferred
- 4+ years of technical experience, including at least 4 years of experience in Regulatory Affairs in the medical device industry.
- 3-5 years of experience in International Regulatory submissions preferred
- Strong understanding of ISO 14971
- Detail oriented with excellent documentation skills, including record maintenance and traceability
- Strong verbal communication and written correspondence skills
- Effective research and analytical skills
- Strong technical writing and editing skills required
- In-depth knowledge of global medical device regulations, standards and guidance documents, as well as regulatory compliance requirements
- Ability to work as part of a project team, as well as independently
- Ability to leverage and/or engage others to accomplish projects
- Ability to maintain regular and predictable attendance.
Some duties and responsibilities are performed in an office environment, and some are performed in a radionuclide production environment with radioactive materials. The job is typically performed under comfortable working conditions; any disagreeable elements are generally absent during normal performance of job.
This position has access to or may be exposed to confidential and propriety Company information. Therefore, a high level of confidentially must be always maintained with any Company information.
LIMITATIONS AND DISCLAIMER
The above position description is meant to describe the general nature and level of work being performed; the position description is not a comprehensive or exhaustive list of all duties, responsibilities of skills required for the position. Management has the right to assign or reassign duties and responsibilities to or from this position at any time.
To perform this position successfully, the employee must be able to satisfactorily perform each essential position duty and responsibility. All position requirements are subject to possible modification to reasonably accommodate individuals with disabilities.