Regulatory Affairs Lead (m/f/d)

TN Germany; Hamburg; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Regulatory Affairs Lead to drive compliance and strategic guidance across the EU. In this pivotal role, you'll manage a team, oversee regulatory submissions, and ensure product compliance. This position offers the opportunity to shape regulatory strategies while collaborating with cross-functional teams. Enjoy a modern office environment, flexible working options, and a comprehensive benefits package that supports your well-being and professional growth. If you are a seasoned leader in Regulatory Affairs with a passion for compliance and team development, this role is perfect for you.

Leistungen

Flexible working hours

30 days of holidays

Employee restaurant with healthy food

100% subsidized public transport ticket

In-house gym

Employee Assistance Program

Comprehensive pension scheme

Childcare support

Bike leasing options

Qualifikationen

• 7+ years in Regulatory Affairs with team management experience.
• Expertise in global regulatory submissions and compliance.
• Strong IT skills with regulatory systems experience.

Aufgaben

• Manage and mentor Regulatory Affairs Managers to ensure compliance.
• Lead regulatory projects and submissions to EU authorities.
• Monitor EU regulatory trends and provide strategic guidance.

Kenntnisse

Regulatory Affairs

Team Management

Regulatory Submissions

Quality Management System (QMS)

Communication Skills

IT Skills

Ausbildung

Bachelor's Degree in Life Sciences

Master's Degree in Regulatory Affairs

Tools

Regulatory Information Management (RIM)

Product Lifecycle Management (PLM)

Microsoft Office

Jobbeschreibung

Regulatory Affairs Lead (m/f/d), Hamburg

Client: Olympus

Location: Hamburg, Germany

Job Category: Other

EU work permit required: Yes

Job Reference: c24d009ffb70

Job Views: 8

Posted: 30.04.2025

Expiry Date: 14.06.2025

Job Description:

• Team Leadership: Manage and mentor two Regulatory Affairs Managers, promoting growth and high performance.
• Strategic Guidance: Advise business units on EU/EMEA regulatory requirements, aligning strategies with business goals.
• Product Compliance: Assess new product launches, ensuring regulatory compliance and offering strategic insights.
• Third-Party Supplier Compliance: Lead compliance efforts for third-party products, collaborating with cross-functional teams.
• Regulatory Process Oversight: Ensure compliance in the launch workflow, including DoC, labeling, certificates, EUDAMED, and DMIDS.
• Business Development Support: Liaise with senior management on mergers/acquisitions, shaping regulatory strategies for new products.
• Conformity Assessment: Lead assessments for existing products, providing risk mitigation advice and ensuring regulatory compliance.
• Regulatory Project Management: Oversee regulatory projects, promoting proactive compliance and continuous improvement.
• Regulatory Intelligence: Monitor and analyze EU regulatory trends, sharing insights with internal teams.
• EU Notification Support: Lead submissions to EU authorities, ensuring timely and accurate filings.
• Marketing Materials Compliance: Review and approve marketing materials, ensuring compliance with regulatory standards and approved claims.
• Product Change Management: Manage product changes across EMEA, ensuring compliance with updated regulatory requirements.

Minimum qualifications include:

• At least 7 years of experience in Regulatory Affairs with demonstrated team management, preferably within a matrix organization.
• Proven experience managing regulatory projects and supporting global regulatory submissions (e.g., 510(k), CE Mark).
• Expertise in preparing regulatory submissions for product commercialization.
• In-depth experience with Quality Management System (QMS) processes.
• Global experience with a strong understanding of international regulatory processes.
• Ability to manage relationships within Regulatory Affairs and collaborate with R&D, Manufacturing, Supply Chain, and Quality teams.
• Excellent communication skills in an international, cross-functional environment.
• Strong IT skills, including experience with regulatory systems (e.g., RIM, PLM) and Microsoft Office.

Candidate Profile:

We seek an experienced leader to manage two EU Regulatory Affairs Managers based in Hamburg. The ideal candidate will provide strategic leadership and expert guidance, ensuring regulatory compliance across the EU, EFTA, and Europe, aligning regulatory strategies with business objectives.

The interview process will be competence-based, assessing the following:

• Build for the Future
• Deliver Results
• Lead People
• Lead Self
• Model and champion Our Core Values

Benefits:

• Flexible working hours, with remote work possible (up to 60%).
• 30 days of holidays per year.
• Modern office environment and employee restaurant with live cooking and healthy food (subsidized).
• Public transport ticket (100% subsidized) or free parking.
• Company sport groups and in-house gym.
• Employee Assistance Program supporting health, mental, and emotional well-being.
• Comprehensive pension scheme.
• Company medical officer and vaccination offers.
• Childcare support through 'Buttje & Deern'.
• Bike leasing options.