On behalf of our client we are working with them on a new role for a Senior Regulatory Affairs Advisor. The role has a 100% flexible approach to work remotely and will suit someone looking for a healthy work-life balance.
PURPOSE / KEY RESPONSIBILITIES:
1. Leads 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, ISO13485 certification applications and others as required by clients
6. Responsible for assessment of complaints in relation to vigilance (EU), MDR (US) and global reporting requirements, where applicable
7. Builds and maintains strong relationships within the European regulatory network including with EU Competent Authorities, Notified Bodies and other stakeholders 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 of the customers
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.
For confidential discussion please contact Tina on +01 2784671 or email firstname.lastname@example.org
Thornshaw Scientific is a division of the CPL Group Log on to www.thornshaw.com
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