Senior Regulatory Affairs Specialist

3 weeks ago

Deeside, United Kingdom ConvaTec Full time

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a FTSE 250 global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence and critical care, and infusion care.

Group revenues in 2021 were over $2 billion. With around 10,000 colleagues, we provide our products and services in over 100 countries, united by a promise to be forever caring. Our products provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.

**About the role**:
The Senior Regulatory Affairs Specialist will support the Global business concerning pre and post market matters and ensure success of the business through completing assigned tasks with mínimal supervision for change control activities, product promotional activities, labeling review activities, product registration and listing database experience, global product registrations requests, export/import activities, and post market actions and associated activities. The incumbent will provide other regulatory support as assigned by their supervisor.

**Duties and Responsibilities**:

- Assure through actions that regulatory compliance for CVT medical devices products are maintained.
- Prepare and update Technical Files to MDD/MDR requirements and associated documents to ensure regulatory compliance for CVT medical devices are maintained.
- Review and load new product listings, product delisting, registration of new manufacturing sites, etc. into the registration and listing databases. Maintain renewals and the up to date information for all appropriate registration and listings databases.
- Complete inquiries and requests from internal and external sources in regard to import/export processes and practices and customs holds.
- Complete all training as required and maintain training plans, records, etc.
- Maintain the organization and the security for all regulatory paper and electronic files.
- Develop, write, implement and maintain RA procedures.
- Complete regional RA requests and provide the requested documents i.e. CFG’s, LOA’s, documentation, etc.
- Review, comment and approve/disapprove change control requests which affect the marketing of medical devices.
- Complete a Letter to File following all US FDA regulations and guidance’s.
- Review and approve/disapprove labeling change request, advertising and promotional request, field communications, etc. in accordance with CVT standards and procedures and labeling regulations and guidance’s.
- Execute, manage and close post market activities i.e. recalls and corrections. Prepare and submit all reporting activities associated with a removal or correction with US FDA and associated OUS Competent Authorities and Regional CVT RA team’s requirements.
- Keep informed about new and revised regulatory requirements.
- Support as requested by supervisor with all other request for information and documentation associated with regulatory laws and regulations.

**Skills & Experience**:

- A minimum of a bachelor’s degree in Science, Engineering, Medical Technology or Nurse required. An advanced degree and/or Regulatory Affairs Certification (RAC) is preferred.
- Minimum of at least 2-3 years of experience in medical device Regulatory Affairs is required.
- Understanding of the regulatory framework for medical devices.
- Understanding of the Quality System Regulations ISO 13485:2016, recalls and correction and labeling requirements required. International experience with recalls and corrections and labeling requirements is desirable.
- Experience with Class I, II, medical devices.
- Familiarity with Class III, products desirable.
- Experience with electronic submission 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 both reactively and proactively and in a timely manner.
- Ability to conduct thorough research of regulatory requirements and related issues to identify potential solutions and available options.
- Ability to plan, manage and execute project-based tasks often with tight deadlines
- Strong analytical skills with good judgment making capabilities.
- Demonstrated organizational skills.
- Strong oral and written communication skills.
- Proficiency with Microsoft Office (Excel, Word, PowerPoint), Adobe Acrobat and Internet-based regulatory resources, Track wise, Documentum etc.

Our transformation will change your career. For good. You'll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you'll be supported to bring them to life. There'll be challenges. But stretch yourself and embrace the opportunities, and you could make your biggest

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