Commercial Regulatory Affairs Lead required by market-leading Irish medical devices company designing & developing life-saving medical devices.
This is a new role created as a result of global expansion. Based at headquarters in Galway, you will be responsible for leading the Commercial Regulatory Affairs team, collaborating with the commercial team on commercial strategy & working closely with the Engineering and Operations team on commercialisation aspects following regulatory approval.
Requirements:
- Degree Level in Law, Engineering, Technology, or Science
- Masters Degree Level in Regulatory Affairs or other similar discipline
- 10 years’ experience in a regulated medical device or pharmaceutical company
- 3+ years in a managerial / leadership position in a regulated medical device or pharmaceutical company
- Thorough understanding of global regulatory challenges and emerging regulations
- Ability to effectively lead the Commercial Regulatory Affairs department with integrity to meet objectives while working collaboratively across departments in a strong growth phase
- Excellent verbal and written communication, planning and co-ordination skills including strong presentation skills
- Ability to demonstrate good business acumen, an understanding of business requirements, identification of and mitigating risks, managing change and working with business partners
- Highly collaborative, team-work orientated and solutions driven with an innovative outlook
- Strong understanding of strategic alignment and effective organisation and co-ordination skills
- Ambitious role model who will enjoy inspiring their team and wider teams to achieve goals and objectives
Key Responsibilities:
- Lead, develop, coach and mentor the regulatory team of senior specialists, specialists, and associate specialists
- Support the team with their career develop plans
- Ensure the team meet the goals and objectives set by the business
- Support the commercial strategy for the business
- Attend the commercial regional meetings, representing the regulatory function
- Provide inputs to the commercial meetings ensuring our commercial partners are kept informed of regulatory changes and challenges for specific countries and/or regions
- Provide prompt and accurate advice to our commercial partners
- Provide mitigation plans for risks that may be present in the business
- Ensure renewals are completed on time
- Provide inputs to distributor agreements
- Ensure authorised representatives are established where required and provide inputs to those agreements
- Confidentially communicate with regulators and/or local agents regarding submissions
- Support the integration partners to ensure they successfully register the product incorporated into their equipment
- Support the R&D, Operations and Manufacturing Teams through the stage gates of the new product development process & for sustaining changes
- Support on site audits, internal and external
- Provides inputs to management review
- Ensure compliance to global regulatory requirements
Please send cv in confidence to emer@emtechrecruitment.ie
