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 leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com
Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as a Senior Regulatory Affairs Specialist, and you’ll do the same.
Job Summary:
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 minimal 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. The role can be based in UK or Denmark
Key Duties and Responsibilities:
Act as RA lead for products under development, liaising with Project Development teams, Project managers including but not limited to R&D, Marketing and Sales and Operations and other QARAC associates. This is to ensure all RA requirements are included in the project plan. Ensure timescales and regulatory pathways are fully understood and baked into the project plan and will be completed. Prepare the pre-marketing documentation for all regions as designated e.g., for CE marking and 510k according to the agreed timeline
Prepare regulatory strategies and update Technical Files to MDR requirements and engage with global markets to ensure global regulatory compliance
Maintain regulatory compliance for a range of Infusion Care Devices via change assessment and management of associated regulatory documentation (eg. Technical file updates, letter to file)
Maintain renewals and the up to date information for all appropriate registration and listings databases, supporting global regulatory teams
Complete regional RA requests and provide the requested regulatory documents
Review, assess and approve change control requests which affect the marketing of medical devices.
Review and approve labeling change requests, advertising and promotional request, field communications, etc. in accordance with CVT standards and procedures and industry guidance's.
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.
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.
Skills & Experience:
Minimum of at least 5 years of experience in medical device Regulatory Affairs is required.
Understanding of the regulatory framework for medical devices.
Experience with Class I, II, III, sterile medical devices.
Familiarity with Class III and active medical devices highly desirable.
Experience in developing and implementing regulatory strategies for New Product Development projects is desirable
Understanding of the Quality System Regulations ISO 13485:2016including preparation and implementation of standard operating procedures
Preferred - experience dealing directly with Notified Bodies, Competent Authorities, and US FDA
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.
Education/Qualifications:
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.
Travel Requirements:
This role will involve hybrid working with occasional travel where needed for team meetings/ work events.
There may be some business-related travel associated with this role dependent on project and / or local market
Attendance of relevant training and development events would be required.
Some destinations may involve overnight or longer stay(s).
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 impact yet.
This is stepping outside of your comfort zone.
This is work that'll move you.
#LI-AC2
#LI-Hybrid
#ForeverCaring
#ForeverConvatec
#WeAreConvatec
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A formal recruitment process is required for all our 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 about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.
Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because 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.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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