|Location||Long Island, New York|
SUMMARY: The Senior Manager, Regulatory Compliance Specialist, Devices, is responsible for ensuring global compliance of BDI's medical device and medical device combination products. This is accomplished through maintained design control and risk processes. Further compliance with the regulations is achieved through monitoring and communications with the ISO Register, Notified Body, the AR, other departments and consultants.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide input regarding compliance to standards and guidance documents globally for medical devices and medical device combination products
- Ensure that Design History Files are generated / compiled and maintained consistent with regulatory requirements and that the files comply with ISO 13485:2016, and the regional requirements of the US, Canada, Australia, Brazil, and Japan, and other regions as applicable
- Ensure that Design Control processes and documentation are consistent with global regulatory requirements of the US, Canada, Australia, Brazil, and Japan, and other regions, as applicable
- Communicate with the ISO Registrar and Notified Body as necessary, to include, but not limited to, facility scope management, product submissions and audit communications
- Review regulation and product changes for impact to the design and risk programs (including the Design History Files) and Medical Device and EU Technical Files and other submission documentation and obtain / provide input as may be required
- Ensure compliance to applicable reference standards and relevant guidance documents and maintain a reference standard and guidance database and oversee review of new and revised standards including generation of opinions by Subject Matter Experts regarding impacts on products
- Provide project planning in order to prospectively maintain regulatory compliance as relates to changes to the medical device compliance regulations or product changes in order to ensure that design (including the Design History Files) and risk documents meet the most current compliance requirements
- Oversee of the Medical Device Risk Management Program consistent with current regulatory standards
- Represent compliance on Medical Device Design Review Teams.
- Participate in Management Review Meetings (MRM) for design controls, risk management and compliance issues
- Maintain the biocompatibility and material composition databases essential to the continued compliance of the products
EDUCATION and/or EXPERIENCE REQUIRED:
- B.S. or B.A. degree in life sciences, engineering or chemistry curriculum.
- At least five years of experience in medical device regulatory affairs
- Working knowledge of FDA, Canadian, and European Medical Device regulations required
- Excellent oral and written skills are required