The Regulatory Affairs Manager (EMEA) is going to provide direct support to Solta operations for their globally distributed products.  They work closely with global regulatory affairs peers, Quality, R&D, Operations to support EMEA licensing and registrations, and to ensure the effective execution and management of changes. In addition, Working as the primary contact for EMEA regulatory intelligence for the regulatory department.

This role may also serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of EU MDR, ensuring regulatory obligations are fulfilled in accordance with applicable requirements.The key responsibilities include, but are not limited to:  

Responsibilities

• Collaborating with Solta’s global regulatory teams in developing regulatory strategies for new product launch and obtain regional product approvals timely for EMEA markets.
• Work as the primary contact for EMEA regulatory intelligence, proactively search and monitor policy, regulation, guidance and standard changes from health authorities, lead cross functions to analyze the impact of regulatory environment changes to the company’s products and business, and update to key stakeholders timely.
• Summarize and provide regional regulatory intelligence report periodically.
• Coordinate and lead the interaction with regional authorities and Notified Bodies.
• Play a key role in interpreting regional regulations, standards, guidance, and registration requirement, provide regulatory guidance to and work closely with Solta’s global regulatory affairs team.
• Provide regulatory input and assessment for new product introduction (NPI) and maintenance of business (MOB) projects.
• Manage & monitor the performance of EMEA registration agencies and local distributors in terms of compliance.
• Create and maintain local regulatory related databases including but not limited to EUDAMED etc.
• Review and approve advertising, promotional materials and labeling to ensure regulatory compliance.
• Represent regional RA to participate in the draft and maintenance of global and local RA related SOPs/WIs.
• Provide strong support to commercial, supply chain, QA team etc.
• Support internal and external audits/inspections as required.
• Ensure the conformity of devices is appropriately checked before release, and that technical documentation and declarations of conformity are properly maintained.
• Oversee post-market surveillance activities and ensure reporting obligations under Articles 87–91 of MDR are fulfilled.
• Perform other duties as assigned.
  

The minimum requirements:

• Bachelor degree or above in engineering, life science, or mechanical discipline;
• Minimum 6-8 years regulatory affairs experience in MNC, regulatory knowledge of other country and region is a plus ;
• Meets the qualification criteria to act as PRRC under Article 15 of MDR: either a university degree in a relevant field with at least 1 year of regulatory experience, or 4 years of professional experience in regulatory affairs or quality management systems related to medical devices.
• Strong technical skills associated with active medical devices, in-depth understanding of EU MDR, experience of laser, RF or ultrasound device registration is a plus, aesthetic device is a plus;
• Expertise and experience in regulatory intelligence, Regulatory database management including but not limited to EUDAMED etc.;
• Good interpersonal skills, team player with the ability to work independently in a fast-paced and dynamic environment.
• Fluency in written and spoken English.

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