Regulatory Compliance Associate
This position performs complex compliance research and regulatory analysis in order to monitor medical device regulations and support business operations according to the strategic plan. This position assesses the compliance of regulatory guidelines to the company's procedures, and processes. This position will assist in regulatory compliance audits that are complex and require significant expertise in regulatory compliance. This position is responsible for the management and oversight of the company's documentation control, complaint handling, CAPA (Corrective and Preventive Action), RoHS certification and compliance, CE certifications, Electrical Safety and EMC compliance and medical device reporting programs.
1) College degree or significant experience in regulatory compliance.
2) Ability to work in a team environment.
3) Self-motivated and disciplined.
4) Strong command of the English language.
Roles and Responsibilities:
1) Under general direction assists in the analysis of the company's regulatory
compliance position and the development of control recommendations.
2) Assists with the analysis and interpretation of all regulatory compliance requirements especially as relates to IVD Medical Devices.
3) Reviews recent proposed activities by regulatory agencies to determine potential
impact on company operations.
4) Monitor and review regulatory and legislative changes, preparing company's response to regulatory changes and following up with appropriate areas to ensure required changes are implemented.
5) Consults with senior management on strategic compliance initiatives and provides corporate compliance perspectives and develop strategy to reduce any potential compliance exposures.
6) Stays abreast of industry and compliance trends; recommends and implements changes to internal company processes as needed.
7) Responsible for answering compliance questions from the field or management.
8) Researches questions regarding regulations, products and competition. Provides
recommendations of means to improve compliance controls, conducts analysis and
creates reports to help improve the compliance of the medical device business.
9) Oversees and manages the complaint process including the responses for medical device reporting requirements.
10) Knowledgeable of current medical device regulations worldwide.
11) Responsible for the management of the company's document control system.
12) Obtains and maintains product CE marks, RoHS, electrical safety, EMC and UL certifications.
13) Maintains Compliance with ISO 13485, FDA QSR and EU IVDD Directives and manages all medical device FDA 510(k) submissions.
14) Assists in all regulatory compliance audits by various certification agencies.
All documents are to be written in English so strong written and structural English skills are required.
• Legal / Public administration
• Attorney/legal advisor/legal councelor
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