Senior Regulatory Affairs Specialist

Overview:

- In coordination with QRA Manager, execute quality and regulatory processes in Emerging Asia (Singapore, Thailand, Malaysia, Indonesia, Vietnam and Philippines)
- Act as Cordis’ QA & RA representative for local authorities under area of responsibility
- Oversee and ensure compliance of the quality activities of 3PL, LSP and distributors in Emerging Asia
- Support acquisition and integration activities of the company
- Ensure that regulatory requirements are met regarding local and national laws and company standards in order to place and/or maintain products on the markets
- Responsible for ensuring compliance with Quality procedures, laws and regulations of the Emerging Asia

**Responsibilities**:

- Support the development of regulatory strategies for products
- Determine applicable registration requirements for medical devices in Emerging markets.
- Develop, document, and implement regulatory strategy for new technologies and product modifications. Ensure strategy is based on current local registration requirements and applicable industry standards.
- Interpret and/or evaluate proposed registration requirements for medical devices and advise on impact of such regulations on the company. Communicate to Cordis changes in Emerging Asia regulations and customs requirements in a timely manner.
- Interface with notified bodies and other regulatory agencies regarding regulatory submission strategy and approval reviews.
- Coordinate complex logístical details including resource and project timeline planning, liaison with functional group representatives and identification/coordination of source documentation.
- Manage and/or oversee communication and submission processes of country registrations including general correspondence, reports and amendments.
- Ensure compliance of Cordis’s Medical Device activities QMS.
- Manage internal and external regulatory audits and inspections.
- Coordinate corrective and preventive actions.
- Manage documentation of the Quality Management System.
- Ensure regulatory and quality training and assessments for marketing and commercial functions, and other concerned employees.
- Contribute to regulatory intelligence (involvement on internal and external working groups, participation at local, national, and international meetings and congresses, as necessary).
- Manage the complaint handling process and coordinate Field Safety Notice (FSN) with Cordis’s Regulatory Compliance actions.
- Coordinate submission issues interdepartmentally to ensure compliance and quick and complete resolution.
- Maintain proficiency on country regulatory requirements and develop and maintain rapport with regulatory reviewers and project team members.
- Support and review final regulatory filings (e.g. product submissions and site/establishment registrations).
- Under direction, review change control documents and ascertain regulatory impact.
- Request and route registration fees to appropriate parties.

Qualifications:

- A minimum of a BS degree, or equivalent in one of the sciences preferred
- 4+ years of experience in related field with 2+ years of experience in Regulatory Affairs in Medical Device industry
- Demonstrated experience in preparing in country regulatory submissions.
- Company acquisition & integration experience preferred
- Overseeing quality activities of 3PL preferred
- Preferred to have experience in GDPMDS

Preferred to have experiences in Singapore, Thailand, Malaysia, Indonesia, and Philippines
- Knowledge of healthcare-related regulations and the regulatory and legislative process.
- Understanding and expertise of regulatory submissions.
- Ability to interface with other functions/departments to assess compliance of proposed claims and labeling submissions.

Ability to provide guidance on regulatory environment, compliance practices, and enforcement strategies.