Senior Regulatory Expert with FDA experience

GBA Key2Compliance is expanding and we need to replenish our specialist team with a senior RA expert with extensive FDA experience. Your skills will be part of what GBA Key2Compliance offers our customers. You will be part of our team of experts who help medical device and IVD companies with regulatory compliance and to get safe and efficient products to the market. Together, we provide the best-tailored advice to each unique client.

Since 1994, we’ve helped companies develop safe products that help people all over the world. Join our team where we have great commitment and where you can develop in your area of expertise!

About the role

As a senior QA/RA Expert you will be part of our team of specialists who work with a wide variety of products within MedTech and IVD. In your role, you will be leading the support to our customers with the US market working with FDA submissions. Most often it is 510(k) but could also be DeNovo’s and PMA’s. You will be able to support them from start to end, and with pre-submission meetings. Apart from working with other members of the QA/RA team, you will also be able to collaborate with colleagues in our other teams; Quality Assurance, Clinical development, Training, and Biocompability.

Each consultant may have between 2-3 projects simultaneously with clients in the small to medium-sized segment. The assignments can often be managed from our office, or from home, but at times require us to be on site. The assignments consist of everything from short-term projects to longer assignments, giving you an interesting variety in your daily work.

About you

We believe you are highly interested in learning new things and have the ability to adapt when the situation changes. You are well-structured, organized, and analytic. You enjoy problem-solving and thrive off challenges. You have strong communication skills in English and Swedish/Danish and believe that teamwork and sharing knowledge leads to the best results.

Key duties

Regulatory work

• Support in development projects
• Regulatory submission with a focus on FDA
• Maintaining contacts with FDA and/or other National Competent Authorities
• Risk management according to ISO 14971
• Compile technical files
• Maintaining contacts with Notified Bodies
• Find effective QA/RA solutions

Staffing

• Act as QA/RA Manager at customers, in short or long assignments

GAP analysis

• Carry out GAP analyzes of Technical documentation regarding legislation and standards.

Generally

• Carry out QA/RA workshops at customers
• Support during the Management review
• Support in the PMS process
• Conduct supplier evaluations

Authorities and Responsibilities

• Carry out your assignments based on a quote
• Report problems to the Director

Qualifications

Education Requirements/Certifications

• 510(k) but could also be DeNovo’s and PMA’s
• MDR and/or IVDR

Required Knowledge/Skill

• Very good spoken and written English and Swedish/Danish
• Thorough but pragmatic
• Solution oriented
• Positive
• Flexible
• Be able to quickly adapt to new social contexts and conditions

Experience Required

At least 7 years’ experience as a Regulatory Specialist or QA/RA Manager at small or medium-sized medical device or IVD companies.

Information and contact details

Place of employment: Stockholm, Gothenburg or Lund in Sweden or Copenhagen, Denmark.
Scope: Full time
Questions: Please contact Director Regulatory Affairs, Helena Dahlin, helena.dahlin@key2compliance.com
Other: We screen the applications and hold interviews continuously so please send your application as soon as possible.

We look forward to receiving your application!

Read more about us here!

Are you interested in GBA Key2Compliance but you don’t feel that this position is the perfect match? Check out our other open positions here!