VP Regulatory / Quality- Medical Device Product Development

ISG, Resources, Inc. known for its Human Capital Management in Medical Device/Biomedical Manufacturing/Design/Engineering has been requested to identify and introduce candidates with the following:

Title:  VP Regulatory Affairs/Clinical/Quality

 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

EDUCATION and/or EXPERIENCE

Bachelor's degree in science or engineering from four-year College or university; ten years experience in regulatory field. Three to five years management experience.  Must have a comprehensive knowledge of US FDA procedures, practices, regulations, and guidelines, including cGMP and QSR requirements and CMDR requirements.

 

Excellent organizational and PC skills.  Strong Word, Excel and PowerPoint skills.  Valid passport or ability to obtain a US passport required.  Must be reliable and able to work independently.

 

MATHEMATICAL SKILLS

Ability to work with mathematical concepts such as probability and statistical inference, and draw conclusions from such data.

 

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

 

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

While performing the duties of this job, the employee is regularly required to talk or hear.  The employee frequently is required to sit.  The employee is occasionally required to stand and walk.  The employee must occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include color vision, depth perception, and ability to adjust focus.

 

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, risk of electrical shock, and risk of radiation.  The noise level in the work environment is usually moderate.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following; other duties may be assigned.

 

Knowledge and training of National and International certified standards including, but not limited to, US FDA Quality System Requirements, Health Canada CMDR, ISO 13485 (current revision), Medical Device Directives, and other certified standards as required.

 

Responsible for interface with European organizations within Client’s Systems GmbH to obtain necessary information required for National and International product registrations.

 

Review of documents and development of regulatory strategies for multiple National and International product registrations including, but not limited to, US FDA Class II and III medical devices, Health Canada registered medical devices, CE Marked product.

 

Responsible for preparing and maintaining National and International product registration regulatory requirements including, but not limited to, US FDA Annual Reports, periodic reports, product registration modifications/amendments.

 

Prepare for and lead all US FDA and foreign facility inspections and US ISO facility inspections.

 

Responsible for ensuring the product complaint system is complaint and all reportable complaints to National and International government agencies based on registered products (e.g. US FDA Medical Device Reporting, Health Canada Mandatory Problem Reporting, European Community Competent Authorities Vigilance Reporting) are submitted on a timely basis.

 

Ensure US FDA Quality System Requirements and ISO training program is performed accordingly.

 

Responsible for approving labeling and also ensuring labeling updates.

 

Responsible for Product Development Activities/Design control.

 

Develop regulatory strategies and manage the regulatory submissions of Client in support of the business plan for each product.

 

Responsible for oversight and communication with European and Canadian Regulatory Authorities in accordance with applicable guidelines and regulations including but not limited to MDD and CMDR.

 

Quality System Management Representative.  Regulatory liaison to US FDA agencies. Manage the compliance of Client (and serve as liaison to DMT) with applicable US FDA regulations. Manage the complaint handling, medical device reporting and product recalls.

 

Advise Client’s Marketing Department and management of issues relating to the US FDA to set strategies and make business decisions. Review promotional information and product literature to ensure they are within regulatory compliance.

 

Develop and manage the implementation of clinical protocols to be used at research/IDE sites to maximize the Client’s chances of obtaining approval regarding specific product or service.  Analyze and present data to US FDA in support of PMA approval.

 

Manage the quality program at Client site to insure compliance with US FDA QSR for any manufactured product and the services/processes that support such product.

 

Reviews governmental rulings to determine changes in legal stipulations and probable effects on company activities.  Identify and report on obstacles to approvals for products.

 

Manage outside consultants (doctors, bio statisticians, etc.) to insure data is accurately collected and analyzed in a cost effective fashion.

 

Manage the technical publications for the preparation of operating and service manuals.

 

Provides support for international quality, regulatory, clinical and reimbursement activities as directed by management.  Direct interaction with various worldwide business entities as well as international agencies will be required depending upon assignment. 

 

Plans and directs the regulatory strategies for Client’s new and modified products as appropriate. Investigates and responds to inquiries and complaints from customers and/or regulatory agencies (FDA). Plans and directs clinical research in support of IDE clinical studies.

 

Interested applicants may apply by submitting their CV and cover letter indicating your

interest, current reasons for seeking new career opportunity, your citizenship status, a day contact number and time when you may be easily reached.

 

BAdamek@isg-resources.com

 

www.isg-resources.com