Senior Regulatory Affairs Specialist

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Pioneering trusted medical solutions to improve the lives we touch, Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Convatec’s revenues in 2024 were over $2 billion and the company is a constituent of the FTSE 100 Index (LSE:CTEC). For more information, visit Convatec Group.

Key Responsibilities

• Act as RA lead for products under development, liaising with Project Development teams, Project managers and QARAC associates to ensure all RA requirements are included in the project plan and that regulatory pathways and timescales are baked into the project schedule.
• Prepare pre‑marketing documentation for all regions as designated (e.g., CE marking and 510(k) according to agreed timelines).
• Prepare regulatory strategies and update Technical Files to MDR requirements and engage with global markets to ensure compliance.
• Maintain regulatory compliance for Infusion Care Devices via change assessment and management of associated documentation.
• Maintain renewal and up‑to‑date information for all registration and listings databases, supporting global regulatory teams.
• Complete regional RA requests and provide the required regulatory documents.
• Review, assess and approve change control requests that affect the marketing of medical devices.
• Review and approve labeling change requests, advertising and promotional requests, field communications and other regulatory documentation in accordance with CVT standards, procedures and industry guidance.
• Keep informed about new and revised regulatory requirements.
• Support the supervisor with all other regulatory and documentation requests.
• Complete all required training and maintain training plans and records.
• Maintain the organization and security of all regulatory paper and electronic files.
• Develop, write, implement and maintain RA procedures.

Skills & Experience

• Minimum 5 years of experience in medical device Regulatory Affairs.
• Understanding of the regulatory framework for medical devices.
• Experience with Class I, II, III, and sterile medical devices.
• Familiarity with Class III and active medical devices is highly desirable.
• Experience developing and implementing regulatory strategies for New Product Development projects is desirable.
• Understanding of ISO 13485:2016 and preparation/implementation of SOPs.
• Preferred: experience dealing directly with Notified Bodies, Competent Authorities and the US FDA.
• Experience with electronic submissions is preferred.
• Experience with US/EU submissions.
• International Regulatory Affairs experience is desirable.
• Self‑starter with the ability to work independently.
• Good time‑management and problem‑solving skills.
• Strong interpersonal and collaborative skills.
• Ability to execute tasks reactively and proactively in a timely manner.
• Ability to conduct thorough research of regulatory requirements to identify potential solutions.
• Ability to plan, manage and execute project‑based tasks, often with tight deadlines.
• Strong analytical skills with good judgment.
• Demonstrated organizational skills.
• Strong oral and written communication skills.
• Proficiency with Microsoft Office, Adobe Acrobat and regulatory resources such as TrackWise and Documentum.

Education / Qualifications

• Minimum bachelor’s degree in Science, Engineering, Medical Technology or Nursing.
• Advanced degree and/or Regulatory Affairs Certification (RAC) is preferred.

Travel Requirements

• Some business‑related travel may be required depending on project and/or local market.
• Attendance at relevant training and development events will be required.
• Some destinations may involve overnight stays.

Working Conditions

• Hybrid working model.

Equal Opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. No discrimination will occur on the basis of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Beware of Scams

A formal recruitment process is required for all Convatec opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address. If you receive a suspicious approach over social media, text message, email or phone call regarding recruitment at Convatec, do not disclose personal information or pay any fees. Contact us at careers@Convatec.com if unsure.

Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Legal
Industry: Medical Equipment Manufacturing