Senior RA Specialist / Associate Manager (Regulatory Affairs)

JOB TITLE

Senior RA Specialist / Associate Manager

DEPARTMENT

Regulatory Affairs

ACCOUNTABILITY

Senior / Regulatory Affairs Manager

DIRECTLY RESPONSIBLE FOR

Senior / Regulatory Affairs Specialist

JOB FUNCTION

• Assist the department head in managing the department activities, and as a designee during his/her absences. Tasks include but not limited to team capacity planning, process improvement, etc.
• Formulate the annual budget and manages the regulatory budget as needed. This include the monthly forecast spending review against the budget.
• Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or changed product launches.
• Write and file appropriate pre-market notification (510k) submission to US FDA; Write and maintain technical file / design dossier for CE marking a Class I, IIa and III medical devices; Write and maintain submission to Health Canada for device licensing.
• Prepare CSTD submission package to Singapore Health Science Authority. Maintain the dealer licenses and product licenses/clearance for importation and sales
• Support the international regulatory specialist within the global regulatory affairs department with product registration in accordance with their local regulatory requirements.
• Maintain current knowledge and stay abreast with the Federal USA polices/guidance, Canadian regulations, EU medical device regulation and Singapore HSA regulation pertaining to legal distribution of medical products. Implements and drives any new medical device requirement within the quality system environment.
• Review and approve scientific and promotional materials as well as documentation change requests to ensure regulatory compliance.
• Communicate the Medical Device Reporting and Vigilance Reporting in accordance with the local authorities’ regulatory requirement. Collaborate with the corporate office to conduct any local field safety corrective actions or product recalls.
• Leads and/or works within department and/or cross functional teams in achieving regulatory affairs initiatives to support departmental goals in alignment to Plant's vision, objectives and shared values.
• Manages, leads, and develops high performing teams. Mentor the team on regulatory submissions.

INTERACTION

Internal parties: • All levels of cross-functional associates and cross-site regulatory counterparts.
External parties: • Regulatory Affairs Representatives, distributors, relevant Regulatory Bodies / Agency and Notified Bodies.

JOB SPECIFICATIONS

Education:

• Degree holder
• Diploma/Advance Diploma

Relevant Experience:

• Preferably with minimum 6 years relevant experiences in regulatory affairs in medical devices.
• Preferably experiences in people management.

Others:

• Computer literate, preferably in MS office.
• Ability to lead, supervise and work in a team environment.
• Strong written and oral communication, and technical writing skills
• Good interpersonal skills.
• Strong critical thinking coupled with sound decision making skills in bringing successful resolution to high-impact, complex, and/or cross-functional problems