Regulatory Affairs & Compliance Specialist - Medical Devices, IVD, SaMD: Ref 072

Regulatory Affairs & Compliance Specialist – Medical Devices, IVD, SaMD: Ref 072

Role Type

Regulatory Affairs / RA Specialist, Compliance Specialist – medical devices, IVD and SaMD

Skills / Experience

Refer to Key Skills section below

Availability

Immediate

Contract Preference

Contract (part time) / fractional

Salary / Rate Expectation

Negotiable depending on duration and no. days per week / month

Profile

Results-driven Regulatory Affairs leader with global experience in regulatory strategy, quality systems, and product development across SaMD, digital health, IVD, and implantable medical devices. Demonstrated expertise in EU MDR, FDA 510(k), and international submissions, with a strong track record of accelerating market access and audit readiness. Proven ability to build regulatory infrastructure and high-performing teams from the ground up, while driving successful product launches and enabling multimillion-dollar growth initiatives.

Ideally suited to working with start-ups and is flexible as to how many days per week / month.

Key Skills / Regulatory Leadership Experience

Expert knowledge of EU MDR 2017/745 and FDA 21 CFR Part 820, with hands-on experience managing 510(k), IDE, and Q-sub processes
Oversight and implementation of global Quality Management Systems (QMS) in accordance with ISO 13485, ISO 14971, and IEC 62304
Strategic leadership in regulatory planning and execution for SaMD, AI/ML-enabled devices, IVDs, and combination products across international markets, including genomic and personalised medicine platforms
End-to-end management of clinical trials and global regulatory submissions (UK, EU, FDA), with a focus on IVD, risk-based classification, and AI-driven health technologies
Proven track record in CE marking, UDI compliance, EUDAMED submissions, and audit preparedness (internal and external)
Experienced in leading and mentoring regulatory teams, cross-functional collaboration, SOP governance, KPI management, and strategic stakeholder engagement
Skilled in managing multimillion-dollar lifecycle management (LCM) projects, aligning regulatory planning with commercial goals and compliance timelines

Experience

Regulatory Affairs Advisor / Head of RA & QA – 2023 – present

Achieved first CE certification under MDR 2017/745 for Class IIb SaMD in 10 months of getting on board.
Launched SaMD product family in 7+ markets, boosting investor fundraising.
Managed regulatory oversight integration across multi-centre clinics in EMEA
Led external audits (NB, ISO, technical file) and coached new team members in audit preparation, participation, and follow-up
Building new QARA team focused on SaMD, compliance, and agility
Supported 3 successful grant application; most recent for £2.2M
Directed FDA submissions (Q-subs, 510(k)); led FDA engagement and strategy

Regulatory Affairs & Compliance PM – 2022 – 2025

Delivered end-to-end lifecycle management oversight across product portfolios valued between $1.2M and $36.99M, aligning RA strategy with business goals.
MDR transition activities, a total of 15 technical files successfully submitted to and approved by BSI. Reduced overall review timeline by 34% (from 22.7 to 15 months) through improved documentation and proactive engagement with BSI. Supported panel preparation, clinical oversight submission, and remediation rollout across multiple submissions, with files progressing from early to late-stage and final review phases.
Planned and executed a strategic product discontinuation project (PDP) that represented 12.3% of the total branch volume, for either continued distribution or market withdrawal. Aligned with MDR constraints and commercial priorities.
Implemented legal manufacturer changes and supported EU-to-US manufacturing transfers, coordinating with supply chain and RA teams to prevent disruption to MDR submissions and maintain business continuity.

Regulatory Affairs Specialist – 2021 – 2022

Supported global registration and compliance for medical endoscopic products.
Managed technical documentation and labelling per EU MDD/MDR requirements.
Liaised with Notified Bodies to facilitate product certifications and regulatory queries.

Regulatory Affairs Specialist – IVD & CDx – 2020 – 2021

Supported client-facing regulatory submissions across the EU for drug-device combination products.
Engaged in labelling reviews and post-approval change tracking.
Participated in cross-functional project meetings to align RA deliverables with study milestones.
Helped sponsor submit MHRA and IRAS

Clinical Trial Operations Manager – 2013 – 2020

CRA to Clinical Operations Manager promotions
Led clinical study operations for investigator-led and academic research trials.
Managed site selection, initiation, and closeout processes; maintained regulatory documentation and ethics approvals.
Oversaw trial budgets and staff training programs.

For further information on this candidate please use reference number: 072

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