In my client’s own words: “We realize that each person who uses our products and services is on their own unique path. In every aspect of what we do, we strive to make a positive difference in that journey”
My client develops and manufactures products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. They are headquatred in the US, but have an office here in Ballina in Ireland, which deals primarily with continence care.
They are seeking for a regulatory manager to join their team and deal, develop and manage regulatory activites across Europe but also collaborate with the US team.
Location: Ballina (Hybrid 2/3 days a month)
Reporting into the VP of Regulatory Affairs, The Manager, Regulatory Affairs develops and implements regulatory strategies to assure timely commercialization of new products in compliance with applicable regulations and standards. This person works collaboratively with cross-functional business partners to execute global strategies, and with external regulatory authorities managing submissions through to approval. This role involves people management.
- Leads the Regulatory Affairs – Continence Care team, who is responsible for supporting new product commercialization efforts. Manages resource commitments for team, ensuring adherence to budget, scope and schedule commitments.
- Promotes and role models proactive and effective collaboration and communication within the team and cross-functionally.
- Recruits, retains and develops talented new team members, gives performance feedback, conducts performance reviews and builds meaningful development plans to ensure high employee engagement, empowerment and performance.
- Serves as an effective business partner who works with cross-functional team members to support new product development efforts. Sets regulatory strategy and guides data development, review and compilation of appropriate technical information for new product submissions, including pre-market notifications, CE documentation and other global regulatory requirements.
- Develops training, provides regulatory guidance, and acts as subject matter expert, to project teams regarding specific product submission strategy, related regulations/guidance and regulatory requirements
Skills and Experience Required:
- Number of medical devices or pharmacuetical experience necessary: 8-12
- Five years Regulatory Affairs experience minimum
- Supervisory experience preferred
- 510k Submission and EUMDR submission experience required
If this role is of interest to you apply immediately for consideration.
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