Job Description

The Regulatory Affairs Manager is responsible for managing the regulatory elements of the Global Unique Device Identifier (UDI) program. These activities include but are not limited to the development, implementation, and monitoring of compliance requirements in accordance with corporate policies, U.S. Food and Drug Administration regulations, EU MDR, and international regulations as they emerge. The Regulatory Affairs Manager will participate in the various data governance improvement activities and support the development and sustainability of regulatory information.

The Regulatory Affairs Manager must be able to develop and implement regulatory strategies and guidance based on U.S. and International requirements as defined in FDA Regulations, ISO 13485 Standard, European Medical Device Directives and Medical Device Regulation, Canadian Medical Device Regulations, Japanese QMS Ordinance (Ministerial Ordinance No. 169), Australian Therapeutic Goods (Medical Devices) Regulations 2002 (No. 236) and other International Regulations. Establish effective dialogue with U.S. and International regulatory authorities.

Job Duties

Manage the Global Unique Device Identification program and regulatory requirements for compliance to the following:

• FDA UDI requirements to meet the regulations (e.g., GUDID, Direct Part Marking (DPM), Point of Use (POU)).
• EU MDR UDI and EUDAMED requirements.
• International requirements to meet the current and emerging market regulations.

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  Manage UDI Team.

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  Label Verification: Ensure data accuracy between labels/artwork and master UDI data.

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  Ensure alignment on project approach and interpretation across manufacturing sites. · Manage the identification, collection, monitoring, and maintenance of all data attributes required for all UDI markets per required timelines.

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  Manage and support UDI project team on all queries and requirements to fulfil international regulatory requests, product registrations, and business needs.

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  Creation and update of Regulatory Standard Operating Procedures (SOPs).

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  Develop and implement training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulations.

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  Function as project member/support for data system or process integration or replacement, data cleansing activities, and process improvements and/or remediation.

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  Monitor developments in international UDI regulations and provide updates on company impact; provides training as required.

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  Participate in industry meetings/working groups as required.

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  Provide input for preparation of the department's budget; ensure that the department operates within capital and expense budget guidelines.

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  Perform all other related duties as directed by supervisor and management.

Job Requirements

REQUIRED QUALIFICATIONS:

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  Bachelor’s Degree required plus 7-10 years of industry experience, Master’s degree with 5-7 years’ experience, or equivalent industry experience.

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  Must have proven ability to manage the Unique Device Identifier (UDI) program and team, including in depth understanding of the Regulation and the impact to the Quality System.

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  Must possess and demonstrate an excellent understanding of FDA, International Standards, Medical Device Directives and Medical Device Regulations, and other International Regulation regulatory requirements.

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  Must be able to travel to Olympus/OSTA facilities in the U.S. and internationally on an as-needed basis.

PREFERRED QUALIFICATIONS:

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  Familiarity with reading and interpreting regulatory data or similar technical information and extracting data from information systems of similar experience preferred.

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  Experience in records and data management.

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  Experience in Agile Product Lifecycle Management (PLM) is a plus.

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  Experience in PowerPoint, Visio, and advanced level of MS Excel.

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  Excellent attention to detail, collaboration and task management.

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  Excellent written and verbal communication skills.

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  Experience in personnel management and development.