Lead Regulatory Affairs Coordinator

Calibre Scientific; Reading; On-site; GBP 40,000 - 70,000; Full time

Job summary

Calibre Scientific is seeking a Lead Regulatory Affairs Coordinator in Reading, England. The role involves ensuring compliance with regulatory standards for In Vitro Diagnostic manufacturing, leading regulatory affairs activities, and liaising with regulatory authorities. Candidates should have a Bachelor's degree in a scientific field and substantial experience in Regulatory Affairs within the medical device industry, with expertise in ISO 13485 and IVDR. This is an opportunity to contribute to a leading company committed to innovation in life sciences and diagnostics.

Qualifications

• Bachelor's degree from a four-year college or university, preferably in science areas.
• Minimum 5 years of Regulatory Affairs experience within a Medical Device or In Vitro Diagnostic company.
• RAPs certification or similar preferred.

Responsibilities

• Lead regulatory affairs activities and ensure compliance with global requirements.
• Prepare and maintain regulatory documentation for IVDR compliance.
• Communicate regulatory updates and assess business impact.

Skills

Expert knowledge of ISO 13485

Communication skills

Interpersonal skills

Collaborative teamwork

Experience with global regulatory frameworks

Regulatory submissions and approvals

Microsoft Applications

Education

Bachelor's degree in science areas

Job description

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About the Company - Calibre Scientific is a global leader in life science and diagnostics, offering a diverse portfolio of businesses that combine the resources of a large company with the agility of a small business. We are committed to providing top-notch customer care and innovative solutions across the industry, ensuring our customers receive high-quality products and exceptional support tailored to their research needs.

About the Role - As a Lead Regulatory Affairs Coordinator you will be responsible for ensuring full compliance with regulatory requirements for In Vitro Diagnostic (IVD) manufacturing within Calibre Scientific UK. You will lead regulatory affairs activities, serve as the primary liaison with regulatory authorities, and provide strategic regulatory direction to support product compliance and market readiness across domestic and international markets. This position demands expert knowledge of ISO 13485, the In Vitro Diagnostic Regulation (IVDR), and other global regulatory frameworks governing IVDs.

Responsibilities:

• Monitor, interpret, and maintain up-to-date knowledge of global regulatory requirements including EU IVDR, MHRA, Health Canada, ANVISA (Brazil), and other relevant authorities.
• Lead the IVDR certification process for all registered products, including the development and maintenance of an ‘IVDR Master Plan’ with clearly defined timelines, milestones, resource needs, and cost estimates.
• Prepare, review, and maintain technical documentation to support IVDR compliance, including STED, PER/PEP, clinical and analytical performance data, risk management files, and post-market surveillance reports.
• Serve as the primary liaison with Notified Bodies, regulatory agencies, and competent authorities to facilitate regulatory reviews and approvals.
• Coordinate and submit regulatory filings to obtain and maintain product authorizations across global markets.
• Lead global product registration efforts, ensuring alignment with country-specific regulatory requirements.
• Communicate regulatory updates and assess potential business impact, providing strategic insights to key stakeholders.
• Participate in site and business meetings to provide regulatory strategy, staff training, guidance on labelling and documentation (e.g., IFUs, SDSs), and support for marketing/compliance materials and audit readiness.
• Ensure regulatory alignment throughout the product lifecycle, from development through market launch.
• Design and deliver training sessions to educate internal teams on regulatory requirements, updates, and best practices.
• Promote a strong culture of regulatory compliance and awareness across the organization.
• Support preparation for regulatory inspections and internal/external audits.
• Establish and maintain risk management processes in accordance with ISO 14971.

Qualifications :

• Bachelor's degree from four-year college or university, preferably in science areas required.

Experience:

• Minimum of 5 years of Regulatory Affairs experience within a Medical Device and/or Invitro Diagnostic company or ISO 13485 certified company required.
• RAPs certification or like preferred.

Skills:

• Expert knowledge of ISO 13485 and IVDR.
• Strong communication and interpersonal skills.
• Ability to work collaboratively in a team environment.
• Experience with global regulatory frameworks.
• Proven track record in regulatory submissions and approvals.
• Expert level use of Microsoft Applications (e.g., Word, Excel, PowerPoint, Outlook).

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Manufacturing

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