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 2022 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
Job Summary
Convatec is a global business providing medical devices to patients across the globe. As we expand our current portfolio and increase our current Advanced Technology field, we are looking for an experienced Regulatory Manager for International Regulatory Affairs. This role will act as a bridge between our international regulatory group and the ‘core’ regulatory team. The role will include coordination of regulatory submissions and development of appropriate documentation and systems in conjunction with both regulatory groups. Furthermore, this role will drive our Medical, Legal & Regulatory (MRL) review processes and Regulatory Intelligence processes, working closely with stakeholder groups. The successful applicant will be integral in the development of international strategy and will interact daily with our global regulatory team.
Key Duties and Responsibilities
- The role will be integral in the development process and provide technical insight into the requirements of international submissions as well as international strategy and function.
- The role will be responsible for driving the processes associated with MRL content review and Regulatory Intelligence, including adherence to procedures and collection and reporting of metrics.
- The successful applicant will manage a small team as well as interacting with the global regulatory organisation (LATAM, APAC, EMEA) in a matrix like structure providing guidance for the international regulatory team on ongoing projects and corporate initiatives.
- You’ll be key in providing details of the international arm of the company regarding strategy and commercial needs to the regulatory and technical groups within the company.
- Liaising with a broad range of domestic groups across the business in relation to any changes to project scope, timelines, regulations etc.
- Gathering all documentation for new submissions and ensuring high attention to detail when dealing with international country requirements.
Travel Requirements
Position may involve travel up to 35% of the time, mostly within UK/US/Europe but overseas travel is expected. Most trips will include overnight travel.
About You
Our successful International Regulatory Affairs Manager will be expected to have…
- Demonstrable submission history experience for US, EU and international as well as knowledge of international submission processes, language skills are also a plus.
- Regulatory degree, while not a requirement, would be an advantage.
- A number of years’ experience within the Medical Device field
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.
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Beware of scams online or from individuals claiming to represent Convatec
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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