Senior Specialist, Medical Device & Combination Product (MDCP) Operations Lead

Job Description

Job Description

This Senior Specialist, MDCP Operations Lead position will serve as the primary medical device and combination product (MDCP) point of contact for the Wilson, NC site Operations team.  Responsibilities for this position will include providing ownership for various MDCP related programs at the site including launch of new products.  This position will be accountable for building MDCP related capabilities at the site and will own efforts to establish and maintain ISO 13485 certification.  This position will also act as liaison between the site and global MDCP teams (Technical, Quality, etc.), providing hands-on shop floor perspective and advocating for processes that are both compliant and pragmatic.

Responsibilities

The Senior Specialist, MDCP Operations Lead position is responsible for providing strategic leadership to the site’s MDCP program.  Primary responsibilities include ensuring that high standards for MDCP compliance are maintained at the site and that key projects related to these products are executed effectively.  Additional activities, responsibilities, and competencies include but are not limited to the following:

Compliance:

• Act as site subject matter expert for MDCP related compliance.  Ensure site operates within established MDCP policies, procedures, ISO standards, and applicable Health Authority regulations (21 CFR Part 4, QMSR, and EU MDR).

• Establish and maintain quality management systems compliant with ISO 13485 standards and relevant MDCP regulations.

• Utilize device risk management tools to build device or combination product risk management programs from development through life cycle management.

• Prepare the site for MDCP related audits by Notified Bodies and regulatory agencies, including hosting audits and addressing audit findings.

Delivery:

• Apply device risk management and design control principles to develop and apply value-add solutions to customer needs in medical devices and combination products.

• Provide support to device assembly, packaging, and other site operations to rapidly resolve concerns and assure compliant and reliable customer supply.

• Provide Business review and approval of MDCP related GMP documentation.

• Collaborate with cross-functional teams to implement corrective and preventive actions based on assessment findings.

• Resolve or escalate MDCP related concerns with the potential to impact product launches or supply.

Cost

• Ensure that activities are carried out in accordance with departmental budget.

• Recognize and implement opportunities related to MDCPs to realize efficiency and financial savings.

People and Team:

• Provide guidance and training to employees on requirements and best practices related to MDCP standards and regulations.

• Develop and execute against strategy to build MDCP capabilities at site.

• Build effective relationships with other functional areas as well as stakeholders across the internal network.

Strategic Support and Continuous Improvement:

• Provide MDCP related leadership to medical device and combination product launches at the site.

• Partner with external stakeholders to develop, commercialize, and sustain medical devices and combination products assembled or packaged at the site.

• Support the company's ISO 13485 certification efforts.

• Execute continuous improvement initiatives to enhance the overall MDCP culture within the organization.

• Establish and maintain effective MDCP-related processes and systems.

Education Minimum Requirement

• B.A./ B.S. degree (preferably in Science or Engineering related field)

Required Experience and Skills

• Minimum 5 years of experience with focus on MDCP product development or manufacturing operations.

• Experience in design controls, device risk management, medical device, combination products, prefilled syringes, autoinjectors, process validation, automation and/or related concepts.

• Thorough understanding of ISO 13485, 21 CFR Part 4, QMSR, and EU MDR.

• Strong communication skills: ability to effectively communicate with cross-functional teams, auditors, and regulatory authorities.

• Experience supporting regulatory inspections (FDA, EMA, etc.) and/or Notified Body audits.

Preferred Experience and Skills:

• Experience with technology transfer of medical device and combination products from development to commer