Senior Regulatory Affairs Specialist

JOB TITLE

Senior Regulatory Affairs Specialist

PURPOSE OF JOB

Key government agencies with direct responsibilities include US FDA, Europe and Singapore. A supporting role to the Regulatory Affairs associates in the local countries to obtain the product approvals. Communicate to the local authority, HSA, for any adverse event reporting and manage any product recalls for Singapore.

• 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 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, 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.
• 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.

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 4 to 8 years of relevant experience in medical device, with minimum 4 years relevant experience in regulatory affairs in medical devices.

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.