Medtronic

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations

Our Purpose  

At CST CMRA & HEPR organization, we strive to be recognized as world class leaders in the field of Clinical, Medical Science, Health Economics, Policy and Reimbursement. We are innovative leaders driving strategies that expand market access, advance cranial and spinal surgery and improve patient lives.  We are committed to delivering solutions that meet rigorous standards of safety and effectiveness while optimizing value for healthcare systems. United in our pursuit of excellence, we strive to transform patient care and set new standards for therapeutic success

Come for a job, stay for a career!

A Day in The Life: 

As Head of BioPharma you will own be the General manager of Medtronic BioPharma; maintaining a management structure, ensuring compliance of BioPharma with all applicable regulations for maintenance of market authorization, manufacturing, distribution, and wholesaler licenses.
The role reports to CST CMRA & HEPR Medical Science Leader.

You will Act as Head of Quality and Regulatory departments to:

Develop, maintain, and improve the Quality Management system of Medtronic BioPharma. Develop, maintain, and implement Regulatory strategies for new medicinal product development, or acquisitions, in line with company strategy.

You will supervise pharmaceutical production and ensure continuity of supply.

As part of your role, you will:

Provide organizational leadership, as well as drive talent acquisition and development.  Ensuring compliance of BioPharma with all applicable license holder responsibilities (EU Dir 2001/83/EC as amended, and Eudralex Vol.4 including annexes), and compliance of pharma sales organization with all applicable regulations. Ensuring compliance of BioPharma with all applicable regulations for maintenance of market authorization, manufacturing, distribution, and wholesaler licenses.  Ensure that an appropriate pharma Quality System is implemented and monitored for its effectiveness. Establish, drive, and execute BioPharma strategies to support the Pharma business for Medtronic.  Implement and lead change management initiatives to ensure smooth transitions and adaptation to new regulatory requirements, market changes, and organizational developments. Manage BioPharma as a shared service cost center and integrate the cost center in the overall Cranial & Spinal Technologies’ P&L, including financial agreements with other OUs and/or geographies outside of Europe. 

Leading Quality Assurance for ensuring that:

BioPharma Quality System is developed, implemented, maintained, enforced, and improved in line with international (e.g. EU and Swiss) pharmaceutical regulations, standards and management guidelines, as well as with Medtronic Corporate Policies, in coordination with all involved country entities. The supervision of all pharmaceutical operations of the company, including (contract-) manufacture, receipt, release, storage and distribution of the pharmaceuticals. Ensuring batch records for components, drug substances and finished products are prepared and reviewed prior to Qualified Persons batch release.
The Quality department works closely together with the Quality and project groups in all concerned Operating Units to establish and maintain alignment with Corporate and Business Unit Quality Management Systems. An appropriate documentation system is deployed and implemented including the archiving. An appropriate training system is in place for the training of BioPharma employees including sales representatives. Systems are maintained in a validated status. An appropriate CAPA process, using appropriate problem-solving tools, is deployed and implemented. An appropriate quality risk management system is maintained, reviews and approves risk management plans for product and processes. Change requests are reviewed, assessed, and implemented as defined in the action plan. Internal and external Quality Management System audits are conducted. Supplier monitoring is in place and efficient. Internal audits are performed annually. Complaints are registered and handled appropriately in a timely manner.

Leading Regulatory Affairs:

Develop and implement regulatory strategies for new medicinal product development, or acquisitions, in line with company strategy. Interface and negotiate with EU Competent Authorities on regulatory issues.  Provide input regarding Medicinal Product Regulatory requirements to obtain timely regulatory approvals as part of the development planning. Organize and lead regulatory submissions to obtain and maintain Marketing Authorization (MA):
o    Establish submission timelines and manage the timely receipt of information required to meeting submission target dates.
o    Review and determine the applicability, accuracy, and completeness of documentations for inclusion in regulatory submissions. 
o    Organize and lead the submission and approval for MA in national, mutual recognition, decentralized and centralized procedures.  Coordinate and support CTAs, IMPDs. Handle of urgent safety restrictions and submissions of safety variations. Handle of requests for information from Competent Authorities. Review and approve promotional materials.  Ensure regulatory assessment and follow-up on any consequential regulatory actions for change control requests are done. Develop and maintain EU Regulatory knowledge of pharmaceutical regulations.  Ensure operating procedures for Medtronic BioPharma are available and followed. Develop and maintain regulatory databases, e-publishing, and e-submissions system.

Key Skills & Experience  

Education:

•    BSC, or Advanced Degree, in a field of science (e.g. Pharmacy, Chemistry, Biology, Medical)

Experience:

Minimum of 10 years Quality Management System experience in the Healthcare industry with a minimum of 5 years in a pharmaceutical environment. Experience with European and Swiss Competent Authorities inspections. Familiarity with EMA Regulatory frameworks, GMP, GCP and other industry standards. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. People Management experience
Skill Set: Committed to meeting, schedules, performance, and budgets requirements. Demonstrates a commitment to excellence by delivering measurable results that equal or exceed stretch targets; customer and results oriented.  Strong interpersonal communication and presentation skills.  Strong analytical skills and data driven. Experience in communicating with Competent Authorities. Strong people management, negotiation, and conflict resolution skills.

Medtronic offer a competitive salary and flexible Benefits Package

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)