At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, technical, high value, innovation solutions. We are committed to fostering an environment that is professional and forth right. These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance. At Pharmatech talent matters, and we tackle each project with a “no fear” attitude. We stand together as a team, and we’ve got your back. Pharmatech’s commitment to integrity is unwavering.
The Clinical & Regulatory Affairs Director – Medical Device is responsible for working closely with the VP of Clinical & Regulatory Affairs and Pharmatech’s sphere leadership to build and execute the strategic plan for the Regulatory sphere as it relates to medical devices, In-Vitro Diagnostics (IVDs), Laboratory Developed Tests (LDTs), Combination Products and Digital Health. This position will participate in regulatory activities across Pharmatech’s portfolio of client’s which span all recognized device and dosage forms and will be the company’s lead Medical Device – Subject Matter Expert (SME).
This position is responsible for leading activities of Regulatory Affairs with an emphasis on global regulatory strategy and the preparation, review and submission of documents to FDA and other regulatory authorities related to medical devices, IVDs, LDTs and digital health. This position will lead teams of multi-specialized SME’s consisting of both employees and Independent Contractors engaged to complete defined project(s).
Within this context, this position will be responsible for the overall direction, coordination, implementation, execution, control and completion of specific projects ensuring consistency with company strategy, commitments and goals.
- The Clinical & Regulatory Director will be responsible for procuring and supporting potential new client sales as a technical expert within the organization for the following:
- Identify and engage potential new clients that will grow the Regulatory organization commensurate with identified growth targets established on an annual basis
- Develop project proposals including scoping of services, staff and cost breakdown
- Work with clients to successfully complete the product approval process
- Identify and secure appropriate project resources working closely with Pharmatech’s recruiting services
- Manage project scope and deliverables
- Develop meaningful metrics to report project performance
- Build and lead a medical device regulatory organization capable of serving the global marketplace
- Formulate regulatory strategies based on current applicable regulatory intelligence
- Oversee implementation of regulatory strategies and activities needed to secure approval of new devices and combination devices
- Ensure the coordination, preparation and timely submission of regulatory documents for clients
- Identify any deficiencies in client product development plans that may pose regulatory issues
- Provide electronic submissions to CDRH as required per current guidelines
- Participate in the development and refinement of the Regulatory sphere’s communication platform, collateral and website content
- Participate in trade shows and actively publish technical information as required to promote Pharmatech’s Sales and Marketing activities
Bachelor’s degree in Science mandatory with a major preferably in life sciences or engineering, e.g., biological sciences, physical sciences, medical science, engineering, or chemistry
Minimum of 15 years of experience of experience in drug development and regulatory affairs experience in the Pharmaceutical Industry. Medical device and/or device-drug combination product related experience preferred. 5 years of formal and direct client management/responsibility in a consulting role is highly desirable.
Must be capable of applying diversified knowledge of regulatory and technical principles and have the ability to prepare regulatory filings or product launches. Must be proficient with cGMP’s, GLPs, ICH, global regulations as appropriate.
Candidate must have direct hands on regulatory experience in device development and approval processes (CE Marking, 510K – DeNovo 510K and Pre-Market Approval (PMA) regulatory submissions) across all phases of development.