Regulatory Affairs Specialist

Welcome to the era of Velsera! Seven Bridges, Pierian & UgenTec have combined to become Velsera.

Velsera is the precision engine company. We empower researchers, scientists, and clinicians to drive precision R&D, expand access to, and more effectively leverage analytics at the point of care.

We unify technology-enabled solutions and scientific expertise to enable a continuous flow of knowledge across the global healthcare ecosystem. This interweaves diverse biomedical communities, allowing them to build upon each other’s success and accelerate medical breakthroughs that positively impact human health.

With our headquarters in Boston, MA, we are growing and expanding our team which is located in 14 different countries!

Regulatory Affairs Specialist

Location: UK/ Europe (Remote)

The Regulatory Affairs Specialist will be an integral part of Velsera's Regulatory team, focusing on ensuring compliance with global medical device regulations and standards. This position will be responsible for identifying compliance gaps for various software platforms and implementing strategies to correct identified gaps. The successful candidate will contribute to Velsera’s regulatory strategy and regulatory submissions.

What will you do?

• Identify relevant regulations for diagnostic software tools in the EU and other markets.
• Perform detailed gap analyses to assess compliance with IVDR requirements and other global regulations for software as a medical device (SaMD).
• Develop and implement plans to address and correct compliance gaps.
• Prepare and maintain documented evidence to support regulatory compliance efforts.
• Contribute to the development of the company's regulatory strategy.
• Assist in preparing regulatory submissions and technical documentation for Velsera and its customers, ensuring accuracy and compliance.
• Lead the implementation of IVDR compliance strategies for Velsera’s software tools, acting as the primary regulatory contact in the EU.
• Support the broader organizational goal of expanding compliance capabilities for future regulatory frameworks across global markets.
• Participate in post-market surveillance activities to monitor product performance and compliance.
• Monitor changes to regulatory requirements and changes in a timely manner.
• Communicate regulatory requirements and procedures effectively across the organization.
• Provide training and support to teams on regulatory practices and tools.
• Assist the company in preparing for external audits from customers and regulatory bodies.
• Work closely with cross-functional teams to integrate regulatory compliance into all areas of the business.
• Mentor team members, fostering a culture of compliance and continuous improvement.

What do you bring to the table?

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.
• 5+ years of relevant industry experience, with a primary focus on in-vitro diagnostics and/or medical device software.
• Experience with IVDR regulations is required; familiarity with other international regulatory frameworks is a plus.
• Proven experience in performing gap analyses and implementing corrective actions.
• Knowledge of standards applicable to Software as a Medical Device (SaMD), particularly those incorporating AI.
• Experience in preparing regulatory submissions and supporting regulatory strategy development.
• Knowledge & experience of managing compliance using software tools.
• Familiarity with quality management systems and standards (ISO 13485, IEC 62304).
• Certifications in regulatory affairs (e.g., RAC) are a plus.
• Positive attitude and a solution-oriented approach.
• Excellent written, verbal, and presentation skills.
• Ability to think proactively and drive improvements in regulatory compliance.
• Strong organizational and project management skills.
• Collaborative mindset with the ability to work effectively in cross-functional teams.
• Ability to coach and motivate others to inspire a positive relationship with the regulatory department.

Our Core Values

People first. We create collaborative and supportive environments by operating with respect and flexibility to promote mental, emotional and physical health. We practice empathy by treating others the way they want to be treated and assuming positive intent. We are proud of our inclusive diverse team and humble ourselves to learn about and build our connection with each other.

Patient focused. We act with swift determination without sacrificing our expectations of quality. We are driven by providing exceptional solutions for our customers to positively impact patient lives. Considering what is at stake, we challenge ourselves to develop the best solution, not just the easy one.

Integrity. We hold ourselves accountable and strive for transparent communication to build trust amongst ourselves and our customers. We take ownership of our results as we know what we do matters and collectively we will change the healthcare industry. We are thoughtful and intentional with every customer interaction understanding the overall impact on human health.

Curious. We ask questions and actively listen in order to learn and continuously improve. We embrace change and the opportunities it presents to make each other better. We strive to be on the cutting edge of science and technology innovation by encouraging creativity.

Impactful. We take our social responsibility with the seriousness it deserves and hold ourselves to a high standard. We improve our sustainability by encouraging discussion and taking action as it relates to our natural, social and economic resource footprint. We are devoted to our humanitarian mission and look for new ways to make the world a better place.

Velsera is an Equal Opportunity Employer:
Velsera is proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, colour, gender, religion, marital status, domestic partner status, age, national origin or ancestry.