Senior Regulatory Specialist (Contract) (CR/4004712) Cork, Republic of Ireland
Salary: EUR50 - EUR70 per hour
Position Summary
We are seeking a dynamic and experienced Self-Employed/Freelance Senior Regulatory Affairs Specialist. This role is pivotal in ensuring our products and services adhere to all relevant regulations and standards. The successful candidate will collaborate with cross-functional teams to facilitate regulatory approvals, manage submissions, and maintain compliance with evolving regulatory requirements. If you are an enthusiastic self-starter with excellent organisational skills and the ability to balance immediate and long-term priorities, we want to hear from you.
Key Responsibilities
* Regulatory Strategy Development: Formulate and execute strategies for product registration, approval, and compliance.
* Daily Regulatory Management: Oversee day-to-day regulatory activities and manage multiple projects related to regulatory compliance.
* Submission Management: Prepare, maintain, review, and submit regulatory documents and applications to health authorities.
* Global Registration Support: Assist the team in obtaining and retaining country-specific regulatory registrations worldwide.
* MDSAP Implementation: Manage the implementation of the Medical Device Single Audit Program within the organization.
* Regulatory Compliance Monitoring: Ensure compliance with national and international regulatory requirements and quality standards.
* Risk Assessment: Identify and assess potential regulatory risks and propose effective mitigation strategies.
* Cross-Functional Collaboration: Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes.
* Regulatory Updates: Stay current with changing regulations, guidelines, and industry trends.
* Quality Assurance Contribution: Maintain high-quality standards within the organization by assessing risk profiles and creating mitigation programs/tools.
* Post Market Surveillance: Manage activities including logging customer complaints and adverse events, coordinating investigations, and conducting regulatory trending and reporting.
* CE Mark Submissions: Handle submissions, significant change notifications, and interactions with Notified Bodies.
* International Filings: Support the team with the preparation of international regulatory filings, including 510(k) submissions and FDA correspondence.
* Material Review: Ensure public-facing materials comply with regulatory standards.
* Additional Duties: Perform other regulatory-related tasks as required.
Essential Skills and Qualifications
Minimum of 8 years of regulatory experience in the medical device industry.
* Educational Background: Bachelor’s degree in Engineering or Science.
* Regulatory Knowledge: Thorough understanding of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, 21 CFR 820, and supporting standards.
* Proven ability to manage projects to deadlines successfully.
* Experience working directly with regulatory agencies.
* Strong ability to manage critical projects as part of an interdisciplinary team.
* Excellent problem-solving and communication skills.
* Highly organized, detail-oriented, and self-motivated.
* Excellent oral and written communication skills.
* Ability to work effectively as part of a cross-functional team.
* Thrives in a fast-paced, entrepreneurial environment.
* Strong skills in technical documentation and report writing.
Desirable
* Certifications: Regulatory certifications in EU MDR and US FDA.
* Advanced Education: Master’s degree in a relevant field.
Name: Please include your first and last name.
Email: @
Phone: Please include your country code.
CV / Resume:
Eligibility: Yes, I am currently eligible to work (work permit/visa/citizenship) in the country to which I am applying. No, I am not currently eligible to work (work permit/visa/citizenship) in the country to which I am applying.
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