Our client, a medical device company in Roscommon is currently looking to recruit a Senior Regulatory Affairs Specialist for their site.
Responsible for providing Regulatory support through the Design and Development and change control process. Plan, prepare and submit regulatory submissions. Provide support to RA with all international country submissions. Support company goals and objectives, policies and procedures, quality systems, and FDA regulations
Employees are expected to support the quality concepts inherent in the business philosophies, including a variety of job-related tasks which may not be specific to this position profile.
- Identifying new regulations and standards that impact regulatory compliance
- Complete technical review, of manufacturing location process validation documentation in line with MDR requirements and update where required.
- Provide technical guidance in relation to regulatory requirements associated with the MDR
- Liaise with all departments to ensure continued corporate compliance
- Support Management review and Management of external 3rd party audits.
- Provide Regulatory support to new product introduction and product transfers teams.
- Plan, prepare and submit regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
- Ensures the biocompatibility requirements of the product are adequately addressed.
- Ensures the clinical requirements of the product are adequately addressed.
- Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
- Ensure the outputs from the individual functional units (engineering, labelling, packaging, marketing etc.) meet the applicable regulatory requirements.
- Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
- Provides support to currently marketed products as necessary including input on change requests, etc.
- Maintains and organises appropriate Technical files and regulatory records to demonstrate compliance with applicable regulations.
Regulatory Affairs Support
- Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
- Provide support to RA with all international country submissions
- Provides support to currently marketed products as necessary including review and approve all related change orders and perform the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements
- Negotiates with regulatory authorities throughout the product lifecycle.
- Provide support to solve and reply to any regulatory query.
- Help to manage and maintain all RA documentation including Technical Master File
- Support all Product design and process changes requiring regulatory support
- Provide ongoing regulatory support to help the team meet its business objectives.
- Customer service - Internal: Develop harmonious working relationships with all functions, and ensure employees have the necessary information (data analysis) and resources to effectively perform their jobs.
- School education level
- University / technical college education level
• Previous regulatory experience in a similar work environment is essential.
- Experience in working Medical Device Manufacturing Facility
- Strong computer skills - Change control management; design, process and system.
- Familiarity with ISO quality systems (MDD 93/42/EEC/MDR - ISO13485 – 21 CFR 820)
- QMS Internal auditing skills
- Good customer relation skills
- Ability to present an independent opinion
- Good communication and interpersonal skills -communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.
- Quality of work / Attention to detail; maintains high standards despite pressing deadlines
- Problem Solving (using recognised tools) and decision making (makes sound factual decisions)
- Risk Management including FMEA generation
For further information on this Senior Regulatory Affairs Specialist role in Roscommon please contact Bimi on 086 8395533 / email@example.com
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