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Regulatory Affairs Manager
vor 3 Monaten
The Manager Regulatory Affairs will be responsible for ensuring product approval according to regulations and maintaining compliance with regulations.
Close coordination with the Quality Assurance team and PRRC is essential to ensure alignment in maintaining product quality and regulatory compliance.
**KEY TASKS & RESPONSIBILITIES**
- Develop and execute regulatory strategies aligned with business objectives, considering regional and international regulations governing medical devices.
- Stay updated on regulatory changes and ensure the company's products adhere to evolving requirements. Interpret and communicate regulatory requirements to internal stakeholders.
- Oversee the creation, review, and maintenance of regulatory documentation, including technical files, dossiers, and submissions required for compliance.
- Keep up to date the technical documentation and the EU declaration of Conformity.
- Monitor industry trends, changes in regulations, guidelines, and standards that impact product development and commercialization strategies.
- Work closely with R&D, Quality Assurance, Clinical Affairs, PMO, and other departments to ensure regulatory requirements are integrated into product development and product design plans.
- Support R&D with development and maintenance of the technical files according to applicable regulatory requirements (e.g.: Risk Management as per ISO 14971 and Design Controls)
- Proactively partner with R&D, Marketing, PMO, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets.
- Provide regulatory input for clinical development.
- Respond to and support Customer Service and Commercial teams on specific requests linked to registration files and regulatory resolutions (i.e. certificate,)
- Review and manage changes to existing Products, SOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
- Lead regulatory assessment of marketing materials.
- Prepare for and support regulatory audits and inspections related to registration file. Ensure readiness by maintaining appropriate regulatory documentation (registration files,..).
- Provide regulatory input for artwork process and approve all regulatory mentions.
- Communicate with competent regulatory authorities (national/international) as well as with notified bodies for registration process.
- Manage Post-Market Surveillance activities (adverse events, medical complaints, and field corrective actions), report in a timely manner, according to the regulation, to regulatory authorities with the support of Medical and with the approval of PRRC.
- Provide guidance and training to team members and other departments on regulatory requirements and changes that affect product development and commercialization.
- Support initiatives to enter new markets by understanding and addressing regulatory requirements of the registration process in different regions or countries.
- Performs staff training on the topic of regulatory affairs.
**EDUCATION/LANGUAGES**
- University degree in Science, engineering field or related discipline
- PharmD is a plus
- English fluent, French a plus
**PROFESSIONAL SKILLS & EXPERIENCE**
- Min 10 years of Regulatory affairs and demonstrated leadership experience in a globally oriented organization in the pharmaceutical/Medtech industry
- Experience managing Regulatory affairs in the Medtech industry, preferably for Class III Medical devices
- Strong understanding of global registration requirements and demonstrated track record of successful market access.
- Excellent understanding of ISO standards (13485, ) ICH, GMP, GDP, GCP, FDA (21CFR’s parts 210, 211& 820, MDR, Healthcare compliance and applicable regulations and industry standards.
- Effective manager with ability to mentor and develop members of the RA teams through coaching and effective performance management.
- Proficiency in Microsoft Office
**PERSONAL SKILLS & COMPETENCIES**
- Strategic thinker, but willing to roll up the sleeves
- Proven people leadership skills.
- High flexibility and ability to handle ambiguity & changes
- Proactive and excellent ability to initiate and self-start complex projects
- Ability to manage multiple projects (PMO knowledge) and complex timelines in a team environment
- Strong negotiation and influencing skills
- Excellent planning, communication and presentation skills
- Strong team player and ability to work across functions
