Regulatory Associate - Belfast, United Kingdom - ARC Regulatory

Description

Job Description

At ARC Regulatory, our experienced team is passionate about supporting the advancement of high-quality biomarker testing in precision medicine research. Our work on +40 precision medicine programmes across oncology, auto immune and cardiac therapy biomarkers, has helped deliver robust clinical data to expedite successful regulatory submissions and global market launches for pharma, laboratory and IVD clients, big and small.

ARC Regulatory continues to create a reputation as a "Great Place to Work". Our commitment centres around employee wellbeing. We enjoy a clearly defined company culture that puts team members, clients and patients, whose lives we seek to improve, at the centre of our day. ARC's investment in career development means there is a career path available and each employee strengthens his/her knowledge of the complex regulatory environment for IVD and CDx medical devices.

Job Purpose:

To be an integral member of and a significant contributor to project team(s) in the development and delivery of global compliance & submission solutions to client companies, ensuring that objectives are met and exceeded at all times. This will require the utilisation of a platinum standard approach to quality assurance, internal and external stakeholder satisfaction as well as an innate work ethic and attention to detail that is aligned with the company's core values.

Key Responsibilities:

· Play an enthusiastic and active role in the formulation and implementation of the short, medium, and long-term business strategy and contributing to KPIs that allow for measurement of success.

· Support the work of the company and project teams in the provision of specialised regulatory assistance to client companies, ensuring expectations and interests are met.

· Research regulatory requirements and prepare elements of regulatory submission documents, including but not limited to global requirements for medical device clinical investigations and IVD performance studies, study risk determination requests, IDE (21 CFR 812), 510(k), PMA, CE Technical Files and Design Dossiers, PMDA Briefing Documents and Submissions etc.

· Assist wider team in understanding the regulatory requirements for an investigational device in the set-up, management & conduct of clinical investigations/performance studies worldwide.

· Manage and keep up to date information relating to regulatory requirements for IVD and CDx medical device studies and maintaining the company's web-based clinical trial planning tool.

· Contribute to the preparation of global regulatory guidance documents and white papers

· As required, take advantage of professional networking opportunities to promote the company and its services to appropriate parties.

· Design and deliver formal client presentations, including proposed solutions and client training.

· Undertake continuing professional development activity to ensure awareness of current quality and regulatory standards.

· Abide by the Company's culture and wellbeing policy, contributing to ARC company culture initiatives to maintain a positive and engaged workforce.

· Any other duties, within reason and capability, as determined by company management.

Qualifications/ Attainments

Essential

• Engineering or Scientific honours degree or equivalent relevant industry experience

Desirable

• MSc or PhD in science related subject
• Current GCP Certification

Relevant Knowledge and Experience

Essential

• 3+ years' experience of working in a medical device GMP/GLP environment
• Experience with IVD design and development, from feasibility to design and clinical validation, regulatory submission and approval
• Knowledge of the regulations relating to medical device/IVD development from feasibility to market (EU/US)
• Knowledge of medical device QMS and CAPA systems (e.g. ISO 13485 or 21 CFR 820)
• Knowledge of medical device risk management (ISO 14971)

Desirable

• Experience of regulatory requirements for companion diagnostics (CDx) in US or EU
• Experience of planning and conducting global regulatory submissions for medical devices (US Q-Sub / 510(k) / PMA / CE-marking)
• Experience of developing global regulatory strategies for medical devices
• Experienced in assisting, from a regulatory perspective, the set up global clinical investigation sites.
• Literature search and medical writing experience

Skills and Competencies

• Excellent interpersonal skills
• Excellent communication skills, both verbal and written, including strong presentation and influencing skills
• Evidence of strong analytical, problem solving and decision-making abilities
• Evidence of well-developed organisational, planning and time management abilities
• Proven ability to achieve results while working independently and on own initiative
• Strong mathematical ability
• Proficient in the use of word processing, spreadsheet, database, and presentation software

Circumstances

• Able to work flexibly as required to ensure business needs are met
• Valid full driving licence and vehicle insured for business use
• Able to travel extensively as required, including European and possibly global travel
• Valid passport