Regulatory Affairs Specialist- Denver, CO

Role and Responsibilities:
Position is responsible for securing U.S. and international regulatory clearance or approval for Spine products/accessories, including developing regulatory submissions and documentation. Incumbent is the regulatory interface during the product commercialization process and throughout the entire product life cycle including post-market surveillance.

Participate as a core team member on cross-functional new product development teams, providing regulatory direction and input.

1.  Develop global regulatory strategies for products in collaboration with other regulatory team members and cross-functional business partners; execute strategies to secure regulatory approvals.
2. Liaise with regulatory authorities as needed in securing global regulatory approvals.
3. Identify regulatory requirements related to specific product development and testing; review and approve technical documentation in support of global regulatory strategies, e.g., test protocols and reports, validation documents, etc.
4. Assist in the development and implementation of required post-market surveillance.
5. Author regulatory submissions/documents, including but not limited to:
   1. Premarket notifications (510(k))
   2. Premarket Applications (PMA) – original or supplements
   3.  Humanitarian Device Exemptions (HDE)
   4. Investigational Device Exemptions (IDE)
   5. Design Dossiers
   6. Renewals
   7. Technical Files

Job Requirements:

1. Bachelor’s or higher degree in clinical/science field, or similar work experience
2. 4-6 years experience in device
3. Requires the ability to work with a variety of levels both within and outside the organization.  Working knowledge of FDA and regulations and how to interpret and monitor them.
4. Knowledge of domestic/international medical device regulations
5. Strong attention to detail
6. Strong computer skills, including word processing, spreadsheet and data programs
7. Good oral and written communication skills

Email dan@scientificsearch.com for consideration

Process Engineer – Wet Chemistry-Willow Grove, PA

Job Description:
Process Engineers work in our client’s in house lab and design and plan equipment and equipment layout for such processes as hardening, washing, laminating, etching, engraving, polishing, painting, plating, and other material processing operations. Plans sequence of operations and specifies procedures for cutting, shaping, and otherwise preparing basic material, exercising judgment in compromising between conflicting requirements, economic evaluation of methods, and operator effectiveness and comfort. Conducts tests and measurements throughout stages of production to determine control over such variables as temperature, density, specific gravity, pressure, and viscosity. Establishes and submits processing requirements to be met in designing and acquiring processing equipment. Responds to customer/client requests or events as they occur. Develops solutions to problems utilizing formal education and judgment.

Qualifications

• A PhD in Materials Science, Chemical or Mechanical Engineering or similar technical degree.
• Demonstrate strong written and verbal communication skills
• Strong knowledge of Statistical Process Control (SPC) and/or Design of Experiments (DOE) principles
• Flexibility in changing priorities and responsibilities to support business needs
• Hands-on participation and a strong sense of ownership
• Demonstrated the ability to work effectively in a team environment
• Experience and knowledge in semiconductor packaging process

For immediate consideration please email resume as a Word attachment to John Barry, john@scientificsearch.com

Director, ePRO Solutions-MidAtlantic Region

The Director, ePRO Solutions is responsible for codifying the Company’s go-to-market strategy and implementation for its ePRO products. The Director will be accountable for driving product sales, clarifying product messaging and market positioning, and collaborating with client delivery teams to optimize the integration between business development and operations. The Director, ePRO Solutions will support the development and launch of  new products and services designed to expand market share, drive sales, revenues, and maximize profitability within his/her product portfolio . Performance will be measured based on: a) Product Sales; b) Publications and Speaking Engagements; and c) Market Adoption of New Products and strategic sales that leverage integrated product solutions. .

Essential Duties and Responsibilities:

• Business Development
  • Support annual Sales Target for assigned product(s).
  • Work closely with Business Development Team to scope and prepare proposals that leverage Product Portfolio and accommodate customer requirements.
  • Actively participate in the preparation and delivery of bid defenses and client presentations.
  • Support the Business Development Team by providing subject matter expertise throughout the sales process to promote new business awards.
• Publication & Research Strategy
  • Leverage research and publication strategy for assigned product(s) to promote market presence and drive sales.
  • Collaborate with Therapeutic Area- and Practice Leaders to guide, oversee and implement research and publication strategy for assigned product(s).
  • As a member of the Company’s Research Steering Committee actively participate in the strategic planning and development of research and publication strategy to advance positioning, market awareness, and growth of assigned product(s).
  • Prepare and present posters, manuscripts, and oral presentations to key publications and conferences.
• Product Development
  • Assist with the Product Development Life Cycle of new products within his/her assigned Product Portfolio.Liaise with customers to solicit feedback regarding satisfaction and interest in assigned product(s) as well as potential new product offerings.
  • Provide market input to Product Development Teams responsible for the implementation of new products and enhancements including development of product plans, sales forecast(s), and prioritization of initiatives.
  • Actively participate in Organizational Readiness planning to ensure the successful transition of new products from incubation to commercialization and drive market adoption and streamline operationalization of new products.

For immediate consideration, email Jeff@scientificsearch.com