Regulatory Affairs Manager level role - Medical Devices - Hybrid working based in Hampshire

Mosaic Regulatory Solutions; England; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A regulatory solutions provider is looking for a Senior Principal Regulatory Specialist to oversee market access and regulatory activities in the EMEA sub-regions. The role requires developing regulatory strategies, engaging with internal teams, and ensuring compliance with regulations. This position offers a hybrid work model of three days in the office, ideal for experienced professionals in regulatory affairs.

Qualifications

• Experience in regulatory affairs and market access.
• Strong leadership and mentorship abilities.
• Ability to develop and implement regulatory strategies.

Responsibilities

• Develop and implement regulatory strategies for corporate projects.
• Review and authorize regulatory documents for product registration.
• Stay informed on regional and national regulations.

Job description

Overview

Job Opportunity: Senior Principal Regulatory Specialist (Manager Level) - PERM

Location: Hampshire (Hybrid role - 3 days in office)

Salary: Available upon application - Excellent package

Are you ready to take on a pivotal role in regulatory affairs? Join us as the Senior Principal Regulatory Specialist, overseeing market access and regulatory activities for EMEA sub-regions, including EU Countries, CIS, ACE, and MENA. Your contributions will be vital in supporting MDD/MDR, CIS, and ACE Country Regulations, collaborating closely with the EMEA Commercial leadership team.

Job Summary:

As the Senior Principal RA Specialist, you will provide expert regulatory guidance from product inception to post-market phases. Your responsibilities include formulating and executing global/regional regulatory strategies, ensuring adherence to regulatory standards, and actively participating in technical audits and regulatory intelligence processes.

Essential Functions & Accountabilities

• Regulatory Strategy and Leadership
  • Develop and implement regulatory strategies for corporate projects.
  • Offer regulatory expertise to project core teams and internal stakeholders.
  • Lead the establishment of regulatory affairs procedures for marketed products.
  • Ensure compliance with global and regional regulatory mandates.
• Registration Activity
  • Review and authorize regulatory documents for product registration in designated markets.
  • Maintain submission documents and agile databases for easy access to regulatory information.
  • Mentor junior team members on regulatory submissions.
• Monitoring and Compliance
  • Stay informed on regional and national regulations, guidelines, and advisories.
  • Communicate regulatory updates to management and business partners.
  • Foster relationships with government bodies, regulatory agencies, and trade associations.
• Product Labelling and Support
  • Evaluate and approve product labelling and marketing materials.
  • Assist "Own Brand" and "Private label" customers, coordinating with EU Competent Authorities.
  • Contribute to Regulatory Affairs Impact Documents (RAIDS).
• Commercial Partnerships
  • Engage with Cluster and Country Leadership Teams

Qualifications

Note: Qualifications are not listed in the provided description.