Regulatory Affairs Manager
Our client a medical devcie multinational currently seeks a Reg Affairs Manager to join their team. Reporting to Senior Director QA/RA the Reg Affairs manager will support the Strategic Manufacturing group to prepare global submission and registration documents in support product transfer activities; complete risk management activities, transfer and maintain technical files/design dossiers for the transfer products. The candidate is required to work effectively with cross-functional groups and global regulatory affairs contacts to maintain worldwide Regulatory clearances/approvals.
Complete the regulatory planning activities for the applicable strategic manufacturing projects.
Clearly communicate regulatory requirements for the strategic manufacturing projects to the project managers andprogram manager.
Participate in project meetings to ensure that the teams remain compliant with regulatory requirements during theplanning, execution and closure of the projects.
Interface with the notified body and/or competent authority to ensure Teleflex is aligned with their regulatoryexpectations for the transfer.
Lead all communication with the applicable notified body and/or competent authority to ensure they effectively schedule resources to facilitate the Teleflex approval timelines and to ensure that they communicate their expectations for the applicable strategic manufacturing project.
Interface with the receiving site quality and regulatory functions to ensure the quality system upgrade and site certification requirements are clearly understood. Co-ordinate the upgrade activities with these functions inalignment with the implementation plan for the project.
Interface with various departments as applicable for the project to ensure all regulatory deliverables are achieved.
Transfer technical files to the assigned legal manufacturer and maintain the technical files once transferred.
Complete risk management and post market surveillance activities to support the technical files at the sending sitesuntil the transfer activities are complete.
Complete risk management activities for the technical files once transferred.
Provide other department support as required by immediate supervisor.
Attract, retain and develop people within the team.
Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all company policies, rules, procedures, andhousekeeping standards.
Degree; desired four-year college degree in Science or Engineering disciplines.
5-8 years medical device industry experience.
Technical writing expertise
Extensive knowledge and understanding of US and international medical device regulations, standards and
Project Management skills and experience.
People Management skills and experience.
Excellent verbal and written communication skills;
Experience with leading and participating in several projects concurrently.• Ability to accurately scope projects and consider the full impact of decisions and actions taken.
Effective communicator of issues, of facts and ideas/solutions to senior members of the organization.
Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to
resolve problems / conflicts.
Excellent interpersonal skills and ability to participate with cross functional teams in projects and innovation.
Ability to communicate and to present reports & ideas.
Functional expert in regulatory affairs with a passion for excellence.
Good business acumen.
Displays ownership of results and a drive to achieve.
Must be fluent in English (Native or bilingual proficiency).
Attention to detail and accuracy – essential.
Complex problem-solving skills for developing creative solutions and meeting objectives are required.
Manage personnel directly or indirectly to achieve the objectives of the applicable strategic project.
Self-motivated to achieve compliant results.
A leader, innovative and imaginative with a forward looking approach and commercial outlook.
James Cassidy | Tel: +353 (0) 1 5079250