Regulatory Affairs Senior Manager, Medtech
|Contact Name:||Larry O’Leary|
Our client, a Medtech company based in Galway, now seeks an experienced Regulatory Affairs Manager to work in a fast paced dynamic manufacturing site on a permanent basis. This leadership role offers opportunity for global technical regulatory affairs strategy development and planning within NPD; in conjunction with managerial, leadership and employee development responsibilities.
The successful candidate will manage domestic and international regulatory activities for the company, including compiling submissions for US, EU and International approvals for Class III and other complex Medtech products.
This hire will have responsibility for regulatory activities related to new product manufacturing and market introduction, as well as regulatory issues relating to labelling, releases, and change orders for multiple product lines, technologies and specialized functions.
Responsibilities for Regulatory Affairs Senior Manager:
Provide regulatory strategies for new product introduction.
Manage departmental procedure development and implementation.
Preview Medtech products labelling, product and manufacturing changes for compliance and applicable regulations.
Manage regulatory activities in maintaining regulatory compliance status of products in commercial distribution.
Manage interactions and relationships with external regulatory bodies on behalf of the company in relation to product approvals and post market compliance
Lead a team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Ensures adherence to budgets, schedules, work plans and performance requirements.
Defines projects based on identified strategies and goals, and manages projects (medium to large scope) including schedules, costs and resources.
Exerts influence in the development of overall strategy, objectives and long-range goals of the organization.
Requirements for Regulatory Affairs Senior Manager:
Honours Bachelors Degree qualified, in Science, Biomedical Engineering or (relevant field).
8+ years' industry experience in a similar role in Medtech / Medical device environment, typically 12+ years industry experience.
People management and team development experience.
Direct regulatory affairs experience with higher class devices.
Proven ability to liaise and work with regulatory bodies.
Proven ability to strategize for regulatory submissions pertaining to new products through product development.
Good organisational ability with attention to detail is required.
Excellent communications skills.
For further details, please contact Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on: Facebook, Linked-in, twitter