Job Description Summary

The Regulatory Affairs Specialist, EMEA is reporting directly to Sr. Regulatory Affairs Manager, EMEA and is supporting the implementation of registration/regulatory strategies for the Waters Advanced Diagnostic (Waters ADx) portfolio.

This role offers location flexibility across EMEA however you will be required to work in the local office 4 days per week.

Job Description

Main responsibilities

This role provides regulatory support for Waters ADx products across the EMEA region, with a strong focus on product registrations, market access and ongoing compliance. It involves assessing the impact of product and regulatory changes, including EU IVDR requirements, to ensure products remain compliant and can be successfully commercialized in the region.

• Operates effectively within a matrix organization to ensure a strong alignment between the regional regulatory strategies and Business Unit (BU) and Country Regulatory Affairs (RA) teams objectives.
• Gathers and compiles technical information, by collaborating with BU RA as necessary, to prepare registration and/or notification dossiers in accordance with local regulatory requirements, support the registration submission processes and ensure Waters ADx product release aligns with their registration status in EMEA.
• Processes regulatory amendments and re-registrations for existing Waters ADx product approvals, ensuring timely and accurate responses; submit requests through appropriate systems where required.
• Recognizes and proposes continuous process improvements and maintain the EMEA Registration databases.
• Conducts Impact Assessments for product changes and/or regulation changes in EMEA to ensure compliance with legislations/regulations.
• Understanding and/or has a desire to obtain knowledge of EU regulatory requirements for in vitro diagnostic medical devices products which may impact the Waters ADx products in EMEA region.

Accountabilities/Skills

More about yourself:

Structured and self-organized, your strong planning, time management and prioritization skills are recognized, including your ability to multitask. Other skills include:

• Demonstrated analytical problem solving.
• Demonstrated ability to juggle multiple tasks and prioritize and schedule work to meet business needs.
• Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; and effective interactions with technical personnel (scientific and legal).
• Demonstrates strong attention to detail with an emphasis on accuracy and completeness of work products.
• Ability to work in an international environment

Other requirements:

• Travel: International travel up to 10%
• Education: Related degree level education required. Higher education is a plus.
• Licenses/Certificates: Industry/function specific certification preferred.
• Experience: 3-5 years or more related industry (e.g. life sciences) experience preferred.
• Competencies: Native level English proficiency, both written and verbal. Additional EU language is a plus.

Please note that the salary range will differ depending on the region.

Required Skills

Optional Skills

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Primary Work Location

BEL Erembodegem - Dorp 86

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. 

The salary or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.

Salary Range Information

€49,100.00 - €74,900.00 EUR Annual