Global Regulatory Medical Device, Combination Products, & CMC Lead

Global Regulatory Medical Device, Combination Products, & CMC Lead

Sobi

Remote, Switzerland

Role & Function

The Global Regulatory Medical Device, Combination Products, & CMC Lead develops the global regulatory strategy for assigned Sobi assets in development and assess the filing strategy of post-approval changes. This role acts as Sobi’s lead for Medical Devices and Combination Products and is responsible for Sobi’s activities in medical device development, registration, and maintenance, on a global basis. The role holder is expected to demonstrate proven experience and leadership in drug/device combination products and in medical devices (including companion diagnostics) development and approval. The role holder will work closely with Global Manufacturing Sciences subject matter experts, Quality representatives, and cross-functional stakeholders in Global Regulatory Affairs. Please note this role is remote but candidate will have occasional travel/meetings in the Waltham MA/Stockholm Sweden offices.

Key Responsibilities

• Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include device (including companion diagnostics) or combination product information;
• Lead New Product Development for Medical Devices (including companion diagnostics) and drug/device combination products to ensure compliance when placed on market;
• Manage the creation and maintenance of Regulatory documentation to support compliance including device technical files;
• Provide expert advice to internal and external stakeholders to support the design, development, and successful approval of medical device(s) and drug/device combination products;
• Act as point of contact and interface with notified (Authorized) bodies;
• Lead and/or author high-quality regulatory documents for global submissions supporting medical devices worldwide;
• Maintain an up-to-date knowledge of global regulations for Medical Devices;
• Evaluate proposed changes for global impact and provide regulatory strategies that support change implementation;
• Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them;
• Represent the Regulatory Affairs CMC function on assigned cross-functional project teams;
• Prepare deliverables to support submissions. Manage answers to questions from the Authorities in a timely and effective manner to ensure approval.

Qualifications

• A Life science degree is required. A higher degree in one of these fields is preferred;
• A minimum of 7-10 years of experience in a medical device and CMC regulatory affairs role including device and product development are required;
• Thorough knowledge and understanding of medical device development and registration globally, including EU MDR requirements and expectations;
• Experienced in liaising with notified (Authorized) bodies and other regulatory agencies;
• Knowledge of key regulatory pathways for pharmaceutical products, medical devices, and drug-device combinations;
• Hands-on experience of authoring technical files or DMF is beneficial;
• Experience with Veeva is beneficial.

Personal attributes

• Good interpersonal skills;
• Excellent communication skills, written and verbal;
• Fluency in English is required;
• Strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds;
• Result-oriented with excellent problem-solving skills and flexible attitude;
• Highly developed respect for timelines;
• In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

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