Senior Regulatory Affairs Advisor
- Experience Level
- Experienced (non-manager)
SENIOR REGULATORY AFFAIRS ADVISOR - MEDICAL DEVICE
On behalf of my client we are working with them on a new vacancy for a Senior Regulatory Affairs Adviser -Medical Device. You get to work with a company that offers autonomy, remote working and other benefits.
Essential skills / Qualifications Required:
B.Sc. Minimum or Engineering primary degree.
Minimum of 5 years’ experience within Regulatory Affairs or Compliance in a Medical Device Environment
Be an authority on global Medical Device requirements & EU Medical Device Directives
Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice.
Excellent written and oral communication skills.
Ability to project manage across a diverse and complex portfolio of products and priorities.
Ability to get on with people, to influence people both internally and externally and to achieve objectives.
Attention to detail and solid interpersonal, communication and organisational skills required.
Ability to work on own initiative with minimal supervision, self-starter and as part of a team.
PURPOSE / KEY RESPONSIBILITIES:
1. Development of appropriate regulatory strategies / project plans for new customer enquiries
2. Lead involvement in the creation of client quotations.
3. Monitor key deliverables/ milestones to ensure budgets are always maintained
4. Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible for close liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval.
5. Preparation of technical documentation for C.E. Marking applications
6. Responsible for assessment of complaints in relation to vigilance (EU), MDR (US) and global reporting requirements.
7. Builds and maintains strong relationships with EU Competent Authorities as appropriate to ensure ease of access and influence.
8. Ensures customer queries are handled in an appropriate and comprehensive manner, and records are kept of all communication both external and internal.
9. Be an authority on the medical device regulatory framework in Europe and US markets
10. Supports EU regulatory initiatives and issues as appropriate for the business.
11. Works collaboratively with other department colleagues to share best practice and information
12. Provide direction and leadership for the development, implementation and maintenance of quality system policies and procedures relevant to the medical device business
13. Ensure that the planning and management of the workload and workflow for the medical device team is carried out to meet company metrics and objectives.
For full details please contact Tina @ +353 1 2784701 or 087 6811990 OR email your CV firstname.lastname@example.org
Thornshaw Scientific is a division of the Cpl group. www.thornshaw.com
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