Executive, Corporate Integrity (RA System & Conformance)

Job Descriptions

Job Responsibilities

01) Lead/manage the entire product change management system, including verifying that the change meets product quality, regulatory, and authority compliance. 
02) Review and prepare the summary on the latest standard, regulatory/authority requirements and ensure the conformance for new requirement. 
03) Verify technical regulatory requirement for country/authority registration matter including product registration, certification, external testing, product & standard compliance, etc. 
04) Liaison with regulatory/ authority agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements and handling regulatory/authority reporting cases including other regulatory/authority concerns. 
05) Provide technical review of data or reports that will be incorporated into regulatory/authority submissions to assure scientific rigor, accuracy, and clarity of presentation. 
06) Develop, implement and maintain standard operating procedures or working instruction according to regulatory & authority requirement to ensure that regulatory/authority compliance is maintained or enhanced. 
07) Communicate and develop regulatory/authority information, requirement and strategy to multiple departments and ensure that information is interpreted correctly. 
08) Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. 
09) Initiate projects that could improve the all conformity of requirement. 
10) Analyse legal agreements based on any regulatory/authority requirement. 
11) Any other task assigned by superior.

Job Requirements

01) A Doctor of Philosophy, PhD in science or equivalent discipline. Knowledge of relevant Regulation, Standard and Compliance requirement for medical device and manufacturing industry. Relevant work experience more than 5 years in Regulatory Affair or manufacturing sector is an added advantage.
02) Good command of English & Malay (spoken and written)
03) Results oriented, strong follow up and good negotiation skills
04) Pleasant personality and able to interact all level of people
05) Problem solving skill to handle regulatory and compliance issue
06) Analytical thinking skill 
07) Good leadership skill
08) Experience of working in an international environment, dealing with a variety of cultures and connecting across various time zones
09) Effective collaborative skills, working with key business stakeholders and cross-functional teams