Regulatory Affairs & Market Access Manager

Rhian_Convatec; Województwo mazowieckie; Remote; PLN 120,000 - 160,000; Full time

Job summary

A global medical products company is seeking a Regulatory Affairs & Market Access Manager to ensure regulatory compliance of products within the CEE market. The role involves creating documentation, supporting reimbursement processes, and building relationships with stakeholders. Applicants must have at least 8 years of experience in the medical device or pharmaceutical industries and possess strong communication skills in English and Polish.

Qualifications

• Excellent oral and written communication skills in English and Polish.
• Previous regulatory affairs experience in pharma or medical devices is mandatory.
• Well organized with attention to detail.

Responsibilities

• Ensure regulatory compliance for Convatec products in the CEE market.
• Create and maintain regulatory compliant documentation.
• Support preparation of technical documentation and reimbursement processes.

Skills

Communication skills in English and Polish

MS Office proficiency

Detail-oriented

Ability to work with stakeholders

Education

8+ years in Medical Devices or Pharma

Job description

About Convatec

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 more than 10,000 colleagues, we provide our products and services in around 90 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. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

About the role:

Our successful Regulatory Affairs & Market Access Manager will be required to ensure regulatory compliance of defined Convatec products within the CEE market and globally, supporting regulatory and reimbursement processes and activities (such as change control), developing strong working relationships with internal and external customers. The person will support the regulatory affairs team with respect to regional and global regulatory projects, including, but not exclusively, product life cycle and regulatory processes. There will be a particular focus on developing strategies and document preparation for products marketed in CEE Region countries. The person will support the commercial CEE team with respect to local reimbursement processes of Convatec products and solutions.

Your key duties and responsibilities:

• Creation, and maintenance of high quality regulatory compliant documentation, as needed for all classes of products per designated franchise responsibilities to ensure regulatory compliance and Pre‑market clearances are achieved in a timely manner
• Provide regulatory support for products or processes undergoing change, liaising with a range of global stakeholders.
• Coordination and leadership of regulatory projects to support the regulatory department
• Support preparation and maintenance of technical documentation for all regions as designated according to the agreed timeline
• Consistently build meaningful relationships and negotiate with key internal and external stakeholders
• Support preparation and maintenance of documentation for product reimbursement processes according to the agreed timeline
• Initiate and cooperate in new Market Access initiatives for new products and technologies with global and local stakeholders.
• Monitor policy changes and payers trends.
• Advises local (PL) HTA, reimbursement submissions, pricing negotiations. Submitt RMB requests, renewal, price increase initiatives for Advanced Wound Care products in "SOLR" RMB System in Poland.
• Consistently drive to create and implement new and innovative ways of doing things.

Skills & Experience:

• Excellent oral and written communication skills in English and Polish – mandatory.
• Very good in Microsoft Office (email, Excel, Word, Power Point),
• Detail oriented approach, creative and solution-oriented person
• Well organized, attention to details, self-managed personality.
• Ability to work in international environment, engaging different stakeholders
• Fluency in another language will be an added value (eg. Czech, Hungarian, Croatian).
• Previous regulatory affairs in pharma or medical devices experience is mandatory.
• Previous medical devices or pharma reimbursement experience is mandatory.
• Local (PL) Market Access / HTA experience will be an added value.

Qualifications/Education:

• 8+ years extensive experience in similar roles within Medical Devices and/or Pharma industries.
• University degree in relevant field desired but not required with relevant experience.

Travel Requirements:

• 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).

Working Conditions:

• This role is based in Poland with a remote working structure. Office presence may be required for certain meetings or events.

Ready to join us?

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

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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.

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