Responsibilities include:

• Direct Quality Assurance activities for sourcing of raw materials, product development, manufacturing & characterization
• Assure company complies with applicable global regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products
• Oversee Quality System activities including Documentation Control, Internal Audits, Quality Records maintenance, and Management Review
• Contribute to preparation of CMC sections for IDE and PMA submissions, and international equivalents
• Interface with US and International regulatory authorities as necessary
• Maintain regulatory procedures and documents to assure continued certification for development, manufacturing, and marketing of products
• Work in a cross-functional team and represent Quality at Product Development team meetings
• Contribute to the development and implementation of process/methods validation protocols and reports
• Audit and oversee activities of contract manufacturers, suppliers and consultants

The qualified candidate will have:

• 12-15+ years experience within medical/pharmaceutical products quality and regulatory environment
• Track record of providing regulatory direction to development, pre-clinical and clinical evaluation, manufacturing, and marketing of combination products, including experience with CMC requirements
• BS in scientific or engineering discipline, advanced degree preferred
• Experience in preparing and obtaining approval of device/drug combination product FDA/ISO/CE submissions and follow-up maintenance activities for approvals and certifications

Industry: Medical Device

Job Code: BHJOB1778_225

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com )

The Director of Regulatory Affairs is a key role in the development, research and commercialization of new products and the management of regulatory and quality disciplines for the organization.  The Director will ensure that the company complies with applicable global regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products.  

Responsibilities include:

• Lead a team of regulatory professionals to define and implement the regulatory strategy
• Lead the preparation, submission, and timely approval of regulatory applications
• Lead the interaction and negotiations with regulatory agencies
• Maintain regulatory procedures and documents to maintain approvals and certification for development, manufacturing, and marketing of products
• Inform senior management of regulatory requirements and status of products and significant regulatory issues/trends

The qualified candidate will have:

• 10+ years of Regulatory Affairs experience with at least 4 years of medical devices and 4 years in senior manager
• 4-year degree required, graduated degree preferred
• Experience in providing regulatory direction to development, pre-clinical and clinical evaluation, manufacturing, and marketing of combination products
• Experience in preparing and obtaining approval of device/drug combination products
• FDA/ISO/CE submissions and follow-up maintenance activities for approvals and certifications
• Significant experience planning for and management of regulatory compliance audits

Industry: Medical Devices, Biologics, Pharmaceutical

Location: Either RTP, NC or Cambridge, MA

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com )

The Senior Process Development Engineer will be responsible for a new pilot manufacturing operation and other current projects and manufactured products.

Responsibilities include:

• Develop and implement manufacturing processes to meet company objectives
• Design, build, acquire, and maintain methods and tools for process improvements
• Conduct process IQ/OQ/PQ in cooperation with QA
• Lead problem solving for manufacturing process issues

The qualified candidate will have:

• Minimum of 5 years in medical device manufacturing and/or product scale-up and development
• 4-year degree required, MS or Engineering degree preferred
• GMP environment experience and training
• Small scale medical device manufacturing knowledge is ideal

Industry: Medical Device, Biotechnology

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

Job Code: BHJOB1778_218

The Wellington Group ( http://www.twgrecruiters.com )