Regulatory Affair Specialist

To provide regulatory support and guidance to PerkinElmer (PKI) business on Diagnostic products. Effectively and efficiently facilitate and maintain the registration of in vitro diagnostic (IVD) products and other Diagnostic products related to the business.

A.   KEY ACCOUNTABILITIES

Responsible to support PerkinElmer business on all regulatory matters concerning diagnostics products by maintaining proper registration and reporting to authorities. Ensuring compliance with all product registration according to local regulatory compliance.Timely preparation, submission, and management of product registrations including follow-up of new product applications, coordination/supervision of product evaluation studies and trials, product renewals, and technical variations to support the commercial team in achieving the business target.Act as a Person in Charge, liaison to local regulatory bodies during the product registration process and ensure completion of the registration is done timely to support the commercial team. Maintain and track the registration status of all marketed products.Serve as the regulatory advisor to PKI business on latest regulation and requirements from local authorities, provide information and training to ensure all commercial team is aware of the latest changes on regulatory.Collaborate with other Global regulatory functions to ensure dossiers submitted to the FDA and other regulating bodies are maintained and updated in line with current regulatory standards and legal requirements.Responsible to maintain all required regulatory documents in accordance to PKI Quality standards and meeting the regulatory requirements in reference to internal and external audit and quality system requirements.

B.   KEY CAPABILITIES REQUIRED

Candidate must possess at least a Bachelor's degree in the area of Life Sciences (e.g. Biomedical Science, BioTechnology, Pharmacy or Equivalent) Minimum 5 years of regulatory affairs registration experience in the position, including successfully registering IVD products.Experience in IVD/medical device/pharmaceutical regulatory activities, which includes experience working within dedicated regulatory affairs environments.Effective collaborative skills, working with the Commercial team. Pleasant personality and ability to interact with all levels of people.Results-oriented, strong follow-up, and good negotiation skills. Problem-solving skills to handle regulatory and compliance issues.A good team player and able to understand the urgency and work with the Sales and Application team to deliver business results.Good interpersonal & communication skills in verbal and written in English.Have own transport and are willing to travel domestically.Computer literate, knowledge of MS Office.