Massachusetts Green Jobs

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:

In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be responsible for leading regulatory strategy and driving registrations across international markets for Convatec's Advanced Wound Care division. This pivotal role involves orchestrating regulatory processes, cultivating relationships with internal and external stakeholders, and managing global/regional regulatory initiatives. Responsible for overseeing the regulatory aspects of new product development, product life cycle, and changes to existing products, with a focus on Class III medical devices. This role encompasses preparation of regulatory dossiers, compliance maintenance, guidance provision, and fostering regulatory knowledge within the organization. As a key member of the team, the Specialist will collaborate with various departments, authorities, and industry committees while contributing to process enhancements and maintaining regulatory compliance.

This is a fantastic opportunity for an experienced regulatory professional to play a pivotal role in shaping Convatec's Advanced Tissue Technologies division's global regulatory strategies and processes. The Senior Regulatory Affairs Specialist will drive compliance, mentor colleagues, and contribute to the company's continued success in the medical device industry.

Duties and Responsibilities :

• Preparation and submission of submit regulatory dossiers (US FDA 510(k) submissions; EU CE marking and UKCA Technical Documentation including Class III devices), and interface with authorities during the review process for

• Advise on strategies and registration requirements for product development and marketed products

• Lead regulatory assessment and actions for product changes and QMS processes.

• Ensure Regulatory compliance to maintain market approvals

• Foster thorough knowledge of regulatory principles and compliance with regulatory policies throughout the organization through training and mentorship

• Regulatory support to enquiries from customers and authorities

• Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes. Supports both new product development and currently marketed product portfolio

• Review, interpret and communicate FDA/EU/international regulations and guidance documents to ensure scientifically sound product submissions

• Support base business activities, such as Annual Reports, Supplements, Labeling reviews, UDI.

• Identify and support or lead process improvement projects to streamline current activities and increase department efficiencies, including the update, enhancement, creation of new internal policies and procedures, and maintenance of existing procedures.

• Supports regulatory compliance to QSR, ISO, MDSAP, CE and other worldwide regulatory requirements as appropriate through customer complaints, internal and external audits, and training systems

• Regulatory review and approval of documents supporting the QMS and product registrations

• Participate as active member of Industry, Regulatory or Scientific Committees

• Serve as delegate for the line manager stated on this job description.

Principal Contacts

• Internal – Marketing, Operations, Regional Regulatory Affairs, R&D, Quality, Clinical, Business-2-Business team

• External - Competent Authorities, Notified Bodies, other international governmental agencies

Travel Requirements: NMT 25% of work time.

There may be some business-related travel associated with this role dependent on project and / or local market and UK travel associated with this role because some team members are home based and face-to-face contact with line manager and peers may be required. Attendance of relevant training and development events would be required. Some destinations may involve overnight stay(s).

Language Skills Required:

• Speaking: English

• Writing/Reading: English

Education/Qualifications:

• Level of education required to have been achieved - Life Science Degree level or equivalent

• RAPS Certification preferred

Competencies:

• Regulatory/Quality experience in medical devices

• Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA

• Hands on experience of creating documentation compliant with FDA CFR 820 and EU Medical Devices Directive 93/42/EEC / EU MDR 2017/745:

• 510(k) submissions, 3-5 minimum

• Preparation and submission of EU technical documentation

• Experience of regulatory requirements for medical devices containing animal derived materials

• Experience of regulatory requirements for medical Devices with an Ancillary medicinal substance

• Knowledge of compliance with key international standards, such as ISO 13485 and ISO 14971

• Demonstrate excellent communication skills

• Demonstrate strong organizational skills, including the ability to prioritize workload

• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial

• Management or supervisory experience preferred

Working Conditions:

• Hybrid role with occasional travel to the Lexington, MA (USA) office.

• Possibility of business-related travel, including potential overnight stays.

• Attendance at training and development events as required.

Special Factors:

There may be rare instances whereby an employee may be required to work outside of non-core hours/days. This may be due to an unexpected event, crisis or project timeline pressure as may occur within the regulatory affairs industry.

Our products make a big difference every day. So will your contribution. The work you do will mean more, because it'll make things better for your team, our business or our customers' lives. It'll inspire you to deliver to your very best.

And we'll be right behind you when you do.

This is a challenge more worthwhile.

This is work that'll move you.

#LI-MH1

#LI-Hybrid

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.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!