Medical Device Regulatory Affairs Lead

4 miesięcy temu

Warszawa, Polska Parexel Pełny etat

When our values align, there's no limit to what we can achieve.
 

We are looking for a Regulatory Affairs Consultant - Medical Device Regulatory Lead for Alliance Combination Products will oversee key regulatory activities and report to the Global Device Regulatory Head for Alliance Combination Products, who in turn reports to the Head of GRA Device. In this role you will provide strategic and tactical support on combination product portfolio and will also have the opportunity to work on other innovative projects. You will work closely with key stakeholders including clinical, medical affairs, Industrial Affairs (Device Development, manufacturing, quality, supply chain) and drug product development. Combination product and drug delivery device systems technology is often exploring new territories that need “new” thinking and approaches from a regulatory perspective. You will be expected to proactively initiate discussions with regulatory authorities and contribute to industry standards and guidelines. This critical and highly visible position offers the successful candidate the opportunity to support a wide range of combination products, from pre-filled syringes, autoinjectors, pumps and other innovative combination product technologies, all of which are part of the exciting development pipeline. 

The role can be home or office based in various European locations.

Key Responsibilities

Serve as Device Regulatory Lead on complex and highly active combination product program teams (typically late stage and marketed products).

Develop innovative and sustainable medical device regulatory strategies covering combination products and delivery systems (device elements).

Provide regulatory guidance and advice to development teams.

Prepare regulatory design control deliverables.

Review and approve design control deliverables.

Lead and/or support global filing and lifecycle management activities for device aspects of combination product submissions.

Contribute to product development planning, including strategies to bridge delivery systems during development and post-approval changes.

Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed.

Ensure regulatory plans are monitored, progress/variance communicated to Management and any risks are highlighted.

Lead and/or support device related health authority interactions.

Provide regulatory impact assessments for proposed product changes.

Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed.

Contribute to internal regulatory processes and procedures for medical devices and combination products.

Engage with the relevant regulatory bodies and industry groups to influence industry standards and regulations, ensuring that the company’s best interests are represented.

Participate and contribute as a subject matter expert per regulatory roles and responsibilities relevant to the device regulatory lead position.

Skills and Qualifications:

University degree in a scientific or engineering discipline

At least 5 years of relevant medical device and/or combination product regulatory experience required.

Sound understanding of and experience with global regulatory requirements for combination products and drug delivery systems.

Working knowledge with technical/industry standards related to drug delivery systems, such as autoinjectors, pumps, etc.

Solid understanding of regulations and guidelines related to drug development and registration.

Proven experience in drug/device combination product regulatory approvals.

Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies.

Ability to synthesize and critically analyze data from multiple sources.

Strong interpersonal skills and the ability to deal effectively with a variety of business areas including medical, scientific, and manufacturing.

Demonstrates excellent communication and influencing skills internally and externally and in particular the ability to impact and influence decisions on global teams, both written and verbal, in English.

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