Regulatory Affairs Manager
Job ID: JOB-12500
Regulatory Affairs Manager
Ready to join one of the truly great companies in Ireland? We have a really exciting job opportunity for a Regulatory Affairs Manager based in Mayo.
Join a super team of people and a company that offers exceptional salaries and rewards.
Let’s have a conversation to find out more about what’s important to you.
The Regulatory Affairs Manager 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.
The Regulatory Affairs Manager maintains proficiency on regulations and provides continuing regulatory education and dissemination of regulatory information to the cross-functional business teams including new product development, global marketing, and clinical groups.
As Regulatory Affairs Manager you will lead a small team. This role will involve up to 20% travel.
- 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
- Consults with internal and external resources during the investigation of regulatory strategy for global projects, and corporate initiatives.
- Provides direction, oversight and ensures quality for Regulatory Affairs projects, assuring that project and business objectives are met in a timely and cost efficient manner
- Determines regulatory impact of product changes and supports timely registration and approval of these changes with governmental agencies worldwide
- Possesses deep knowledge, and ability to apply understanding, of medical device regulations
- In depth knowledge of GMP and GXP
Education & Requirements
- Number of relevant years of experience necessary: 8-12
- Five years Regulatory Affairs experience minimum
- Supervisory experience preferred
- 510k Submission and EUMDR submission experience required
- Bachelor’s degree in scientific discipline required, M.S. preferred.
Specialized Skills/Technical Knowledge:
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- Local Specifications (English and Local Language):
- Demonstrated knowledge and effective application of regulations and standards for the US and EU, including US FDA medical device clearance process, the Medical Device Directive, ISO 13485, ISO 14971 and ISO 10993.
- Strong written and verbal communication skills, including the ability to clearly and concisely articulate complex concepts to a lay audience.
- Strong interpersonal skills – able to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned job responsibilities.
- Demonstrated ability to spot issues and provide incisive, practical and business-focused support and advice.
- Demonstrates an ability to apply new approaches to problem solving
- Demonstrates an interest in and understanding of industry developments and trends
- Project management skills a plus
- Clinical Trial experience a plus
For further information on this role please contact Elaine Ferguson on Connect@hero.ie or 087-4108620
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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