Description
At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate the success of large complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape organizations require regulatory affairs professionals who can navigate complex and fast-changing laws regulations and public policies across the globe.
In this context we are looking for regulatory affairs experts in the med-tech space to play a key role in driving Oracles success and competitiveness in the healthcare and life sciences sector.
You will work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries. This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. For this role we are seeking a regulatory strategist who is collaborative a creative problem solver and dedicated to excellence in their work.
What Youll Do:
Preferred Qualifications:
Strong problem-solving planning and organizational skills with the ability to manage multiple priorities and work independently in a fast-paced cross-cultural environment.
Experience in working within a quality management system preferably with ISO 13485 ISOCFR parts 1000/1001
Understands continual improvement and risk management. Excellent written and verbal communication skills.
Experience engaging with regional trade associations industry groups or regulatory forums.
Ability to adjust and adapt to changing priorities in a dynamic environment.
Ability to perform in a fast-paced and continually evolving business environment.
Performs evaluation of internal operations controls communications risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Conducts and facilitates internal and external audits to identify evaluate disclose and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters. Support the creation of a comprehensive risk management and/or quality management and regulatory oversight program including specifications for product and service design aligned with Oracle Software Security Assurance and Security Architecture and/or Quality Management systems. Review specifications. Develop training for GBU development cloud services services and operations teams on industry regulatory specifications applicable to their products and services. Execute risk assessments and evaluate risks to the business and develop risk mitigation strategies. Identify industry requirements applicable to Oracle GBUs and work with members of GBU development cloud services services and operations teams to incorporate applicable industry regulatory standards Oracle security and/or quality policies and customer-contractual obligations into GBU processes and standards. Coordinate industry and regulatory certifications including managing certification vendors (e.g. PCI HIPAAHITECH ISO SOC2). Build security documentation and collateral for customers and internal users allowing security to be a differentiator in this GBUs. Build management level metrics and reporting for activities that are owned by the Risk Manager. Execute a vendor security and/or quality management program.
Career Level - IC4
This listing is sourced from a third-party job board. Applying will redirect you to the original posting.
First Abu Dhabi Bank
Marriott Hotels & Resorts