Senior Manager Regulatory Compliance, Devices

Lawrence Harvey

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :

Bachelor of Business Administration,Bsc,Master of Businees(MBA)

Address 1 :

North America,--NewYork,Long Island,

Key Skills :

Senior Manager Regulatory Compliance, Devices

Salary :


Date Posted :

03 Oct, 2018

Company Name :

Lawrence Harvey

Location1 :

Long Island

Job Category :

Biotech Jobs

Experience :


Job Type:


Travel Amount:



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.


- 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


- 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

Company Name:

Lawrence Harvey


150 Leadenhall Street,London


Staffing Firms


United Kingdom





100 - 499


Pharmaceutical Recruitment



Phone No. :

0203 327 3072

Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

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