Senior Regulatory Affairs Specialist (Global Registrations)

Senior Regulatory Affairs (RA) Specialist

 

Are you an experienced Regulatory Affairs (RA) Specialist with expertise in global registrations looking for a new permanent opportunity? We are currently partnering with an innovative medical device company that is rapidly growing and seeking a Senior RA Specialist to oversee global registrations and collaborate with distributors and consultants. If you have a passion for regulatory affairs and project management, this could be the next step in your career!

 

About the Role

As a Senior RA Specialist, you will:

• Weekly project management meetings with various distributors/consultants regulatory professionals
• Build Clear regulatory pathway maps/gannt-charts per country per device with milestones, deliverables, requirements (Dossiers, local labelling), time lines, cost.
• Clear agreements with distributors and consultants on who creates what (dossier (re-)formatting, translations, addition country specific documents)
• Ensure all dossier updates are uploaded in our eDMS, approved by appropriate stakeholders and RA. Tracking of doc versions submitted.
• Transfer labelling requirements (IFU, patient cards, leaflets, box labels), possible eIFU etc., to RA and QA.
• Plan labelling changes implementation time lines with Operations, QA, RA.
• Chair weekly Dashboard for management with progress updates, issues, and escalations
• Chair weekly team meetings to update internal stakeholders in Marketing, Sales, RA, QA

 

This is a fantastic opportunity for an experienced professional to join a growing organization where you will have the chance to directly impact the company’s regulatory success across multiple international markets.

 

Why This Role?

Growth Opportunities: Join an innovative medical device scale-up that is expanding rapidly across multiple regions, offering significant career development prospects as the company grows. Inclusive Culture: Work in a supportive, collaborative environment where team members are valued for their expertise, and cross-functional communication is key to success.

Dynamic Environment: Experience a fast-paced, international working environment with a forward-thinking company that values innovation and continuous improvement.

 

What We’re Looking For

• Experience: At least 5 years of experience in Regulatory Affairs (RA) within the medical device sector, with a strong background in managing global registrations.
• Project Management Skills: Strong project management experience, including the ability to facilitate cross-functional teams, track timelines, and meet deliverables.
• Communication Skills: Excellent communication skills, both written and verbal
• Regulatory Knowledge: In-depth understanding of global regulatory processes, including dossiers, labeling requirements, and eDMS management.
• Team Player: Ability to work collaboratively with internal teams, distributors, and consultants to drive successful outcomes.
• Languages: Fluency in English is essential; additional language skills are a plus.
• Location: Hybrid model with 60% onsite required. Onsite collaboration expected during onboarding.

 

Ready to Take the Next Step?

If you're an experienced RA Specialist with a proven track record in global registrations and project management, apply now or reach out to Aimee Brenner at a.brenner@panda-int.com for more details.

 

Interviews for this position will take place in early January.