Regulatory Affairs Specialist
Location:UK/ Europe (Remote)
Who are we?
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 rapidly growing!
TheRegulatory Affairs Specialistwill 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.
- Soft skills:
-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
What do we offer?
Velsera stands for a stimulating atmosphere where you can grow your capabilities in an open company culture. We want you to do the work you feel great at, or that you would like to become great at. You’ll work for a mission driven organization that is making a true difference in the scientific and healthcare space.
Next to that, we offer competitive salaries including:
A full-suite of industry leading benefits (list by location)
Remote work flexibility
If you feel like this could be the next big thing for you, make sure you’re not going to miss out and have a chat with us!
Competencies
Networking
The ability to develop and maintain relationships within and outside the organization for effective communication and collaboration
- looks beyond cultural differences and other barriers in their search for useful connections
- contacts other departments to increase the success of their own project
- works cooperatively with their network to support their work and grow professionally
- involves others in their professional networks and encourages them to expand these
Creativity
The ability to initiate original, innovative ideas and solutions, and to adopt points of view outside the usual parameters.
- Is unafraid to suggest bold changes or ideas
- is able to connect concepts and views from different disciplines
- regularly provides new ideas without being prompted or guided
Integrity
Adherence to the standards and values associated with the department and the culture in which one operates.
- exerts power carefully
- makes sure that colleagues displaying unethical behaviour are corrected
- adheres to appointments at organisational or departmental level
- maintains integrity by keeping promises made at any level of the organization
Our core values
People first.We createcollaborativeandsupportiveenvironments by operating withrespectandflexibilityto promote mental, emotional and physical health. We practiceempathyby treating others the way they want to be treated andassuming positive intent. We are proud of our inclusivediverseteam andhumbleourselves to learn about and build ourconnectionwith each other.
Patient focused.We act with swiftdeterminationwithout sacrificing our expectations ofquality.We are driven by providing exceptional solutions for ourcustomersto positively impact patient lives. Considering what is at stake, wechallengeourselves to develop the best solution, not just the easy one.
Integrity.We hold ourselvesaccountableand strive fortransparent communicationto buildtrustamongst ourselves and our customers. We take ownership of ourresultsas we know what we do matters and collectively we will change the healthcare industry. We arethoughtfulandintentionalwith every customer interaction understanding the overall impact on human health.
Curious.We ask questions and actively listen in order tolearnandcontinuously improve. Weembrace changeand the opportunities it presents to make each other better. We strive to be on the cutting edge of science and technologyinnovationby encouragingcreativity.
Impactful.We take oursocial responsibilitywith the seriousness it deserves and hold ourselves to a high standard. We improve oursustainabilityby encouraging discussion and taking action as it relates to our natural, social and economic resource footprint. We are devoted to ourhumanitarianmission 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, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
