Director Regulatory Compliance

Director Regulatory Compliance

Biocartis

Mechelen, Belgium

The Director Regulatory Compliance is a key team member to develop and market Biocartis assays. The Director Regulatory Compliance will manage registrations with authorities, formulate strategies to ensure department operations align with overall business objectives, manage regulatory budgets and on-market surveillance activities.

Accountabilities

• Accountable as Person Responsible for Regulatory Compliance (PRRC) as defined by the IVDR. In this respect, the role includes, but is not limited to, the following accountabilities:
  • Conformity of IVD medical devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before the device batch is released. Signature of the PRRC or delegate on the IVD batch Certificate of Analysis will constitute evidence of this conformity check;
  • Confirmation of the completeness of IVDR Technical Documentation generated from the device Design History File (DHF), as confirmed by signature of the PRRC or delegate on the EU Declaration of Conformity for the subject IVD medical device;
  • Confirmation of the completeness of regulatory submissions to various regulatory authorities, as confirmed by signature of the PRRC or delegate on required declarations;
  • Ongoing conformity of the IVDR Technical Documentation and DoC, as well as other market regulatory submissions, when managing proposed changes to the IVD medical device throughout the lifetime of the product;
  • Biocartis establishment and maintenance of a post-market surveillance system compliant to requirements of the IVDR and other market expectations for on-market compliance, including accuracy of claims in advertising and promotional materials;
  • Vigilance reporting to regulatory authorities in conformity with the market-specific reporting requirements;
  • Confirmation and declaration of safety for IVD products intended for performance evaluation within interventional clinical performance studies.
• Responsible for overseeing effective on-market surveillance and vigilance activities including Regulatory review of product complaints;
• Represent the company on working groups for IVDR and US FDA;
• Manage communications with FDA and other regulatory authorities, and act as the key contact with investigators/auditors during audits;
• Work closely with R&D teams to design and implement acceptable processes securing compliance to EU, US, Japanese and other regulations;
• Work closely with R&D teams to implement development efforts compliant to the IVDD, pending IVDR, US 21 CFR 820, and global regulatory requirements;
• Work with Clinical Affairs to create clinical validation strategies to meet expectations of regulatory authorities including US FDA;
• Provide advice and input in regards to new CDx and partnering opportunities ensuring that regulatory input is taken into account in managing expectations on timelines and commitments to external parties;
• Provide coaching and guidance to regulatory professionals.

Profile requirements

• Bachelor’s, Master’s or Doctorate Degree in a scientific, clinical or regulatory discipline or equivalent through experience or training;
• Minimum 10 years of experience in Regulatory Affairs; IVD regulatory international registrations preferred; Minimum 5 years as a regulatory lead and/or regulatory team coach, and as a regulatory lead for complaint management and medical device vigilance reporting;
• Must have highly effective organizational and planning skills to apply daily in a multidisciplinary environment;
• Must be able to work effectively in a strongly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Development, Manufacturing, Quality, Marketing, Operations and corporate partner counterparts;
• RAC Certification a plus;
• Applied understanding of the application of Regulations;
• Well-developed technical writing skills/Experience writing regulatory submissions;
• Solid understanding Product Development Process & Requirements;
• Solid understanding QMS and GMP expectations (ISO13485 & 21CFR820);
• Solid understanding and applicability of standards and guidelines (eg ISO14971; CLSI; EP7 etc.);
• Solid understanding of Idylla products and comparable products;
• Solid understanding of Clinical (Design) validation expectations;
• Legislation and regulation:
  • US CFR Title 21 (applicable sections);
  • IVDD & pending IVDR;
  • GDPR;
  • Various Market Regulations.
• Planning & organization – Strategic planning, sets goals and priorities for Life Cycle/Functional or Business Area/Biocartis and aligns people, processes and structures with strategic direction;
• Adaptability to change – Managing change: leads changes to meet shifting business needs and challenges, acts as a catalyst for organizational change;
• Strategic Thinking – Translates Biocartis vision and strategy into SMART plans for team;
• Coaching & development – Provides ongoing feedback, creates development opportunities and plans to meet employees' needs and aspirations;
• Communicating & influencing – Communicates with impact, handles strategic communication to internal and external stakeholders effectively;
• Analytical thinking – Performs complex data analysis with impact on the company, makes evidence based judgements that guide organizational decisions;
• PC skills:
  • Applied knowledge of MS office (Outlook, Excel, Word, Powerpoint);
  • Applied knowledge of an ERP system, preferably Microsoft Dynamics AX.
• Languages: fluent English, written and spoken.

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