Global Regulatory Medical Device, Combination

At Sobi, each person brings their unique talents to work as a team and make a difference.
We are dedicated to developing and delivering innovative therapies to improve the lives of rare disease patients. and our edge comes from our team of people.

**Role & Function**

**Key Responsibilities**
- 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.

**Why Join Us?**

We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

**Sobi Culture**

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.

This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain.

Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

**An Equal Opportunity Employer**

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