Remote Head of Global Regulatory Affairs Medical Device

Retained Search

Our client is an established and growing Global Medical Device/Technology company fueled by knowledge, passion, collaboration, and integrity. With operations in Australia, Europe, the US, and Aisa.  In this role, you will be responsible for developing and leading the Regulatory strategy and providing strategic and operational leadership to the organization.  The Head of Regulatory Affairs will be accountable for prioritizing the pipeline and overseeing programs through development for regulatory approval, as well as life cycle management opportunities for already approved and marketed products. This is an exciting time to join this rapidly growing organization.

Responsibilities:

• Lead global regulatory oversight and support of the global development, registration, and life-cycle management of programs.
• Responsible for oversight of the health agency meetings (FDA, EMA, TGA, MHRA, etc.) and strategic planning.
• Providing regulatory advice to the business as it impacts the commercialization strategy of the company’s products.
• Lead global oversight and support of the organization’s regulatory compliance initiatives.
• Identify and monitor current regulatory requirements the QMS must satisfy to operate legally within the jurisdictions the company targets for product release.
• Represent the company with senior customer representatives, partners, regulators, suppliers, associations, or other bodies as required.
• Engage consulting services in support of the role’s responsibilities where appropriate.
• Actively engages with industry organizations (ARM, DIA, RAPS, etc.) to drive cross-industry best practices and support evolving global regulatory guidance.
• Engage with company leadership roles such as the Global Quality Manager and GM-NPI for the establishment of efficient and effective business systems for the delivery of compliant products to customers.
• Manage all necessary engagement with Notified Bodies to support products in the market.
• Support the company’s due diligence on potential acquisitions in regulatory matters.
• Provide input to the business units and reporting to the CCSO, including via Management Review process, recommendations for improvement, and emerging regulatory compliance risk and mitigation.

Qualifications:

• B.S./B.A. in science, engineering, or related technical field is required, Regulatory Affairs Certification a plus.
• Minimum ten years’ experience in a senior regulatory affairs leadership role which encompasses a close working relationship with the FDA for medical device or combination products.
• Excellent oral communication skills and demonstrated ability to present, influence, and create solid partnerships with executive leaders and regulatory agencies and trade associations.
• Proven success in building, developing, and driving team success.
• Inspiring leader that creates energy, enthusiasm, and delivery of simultaneous high-impact projects and results.
• Previous experience in a Quality Assurance capacity with responsibility for regulatory compliance and continuous improvement initiatives in a science-based and/or technologically sophisticated manufacturing environment.
• An in-depth working understanding of Quality Management Systems, ISO 13485, and/or equivalent to support MD/IVD products (class 2 or higher preferred).
• Experience in partnering with internal and external stakeholders on key issues or submissions.
• An expert-level understanding of Compliance and Risk Management (ISO14971 preferred).
• A strong commercial acumen with an ability to apply regulatory requirements in a commercial environment.
• Ability to represent the company appropriately with senior customer representatives, partners, regulators, suppliers, associations, or other bodies as required.

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