HEAD OF REGIONAL REGULATORY REGISTRATIONS- EBD

Sinclair is looking for a Head of Regional Regulatory Registrations to oversee Post Market Regulatory Teams for the Electrical Based Devices (EBD) business unit. In this role, you will be responsible for managing post-market regulatory matters, and ensuring compliance with all relevant legislation and guidelines to achieve and maintain authorizations and registrations for Sinclair Group products, including active medical devices, cosmetics, and PPE. You will work across various global markets (APAC, MEA, LATAM, CEE, CIS, and EU) to meet agreed targets and schedules. This position offers a unique opportunity to drive and enhance regulatory processes, supporting the global expansion of our products and ensuring compliance with international regulatory authorities.Location: Barcelona / Spain (possible to work remotely)About SinclairFounded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.Our VisionProviding aesthetic excellence globally.Our Mission Driving the advancement of product quality and customer satisfaction, investing in innovation and people.Our ValuesAct with IntegrityBe results drivenEmbrace your winning spiritStay ahead of the gameOne team, one goalYour Responsibilities:To lead the Post Market Regulatory team in the EBD division, providing expert knowledge and guidance on regulatory legislation and guidelines for Sinclair Group products in RoW territories, ensuring adherence to Sinclair Group procedures and policies and alignment with the Post Market Regulatory strategy.Offer regulatory advice and guidance to Sinclair Group personnel to assist them in their roles and responsibilities.Collaborate with commercial managers to identify opportunities for market expansion, renewals, and partner transfers.Work directly with the Regional VPs of commercial and Chief Strategy Officer to implement regulatory strategies for new, renewal, and transfer registrations in line with business and commercial priorities.Prepare and implement Post Market Regulatory strategies associated with the EU MDR for the Sinclair Group.Implement and maintain Sinclair Group Post Market Regulatory procedures and processes, focusing on compliance, efficiency, and continuous improvement.Assess risks associated with shipping non-compliant/non-approved products and provide clear overviews to the Senior Leadership team.Evaluate changes to RoW regulations and requirements, communicate changes to key stakeholders, and plan and implement actions required to align Sinclair Group products, registrations, processes, and procedures with these changes.Complete RoW Regulatory Change assessments for all Sinclair Group changes, coordinate partner change notifications, and determine RoW rollout strategies.Communicate directly with partners (in-country distributors, regulatory agents, etc.) to determine country-specific regulatory requirements.To monitor Post Market Regulatory team resources across both divisions and escalate potential capacity risks.Ensure the Post Market Regulatory team tracks and monitors all submissions, communicating any known or potential risks to relevant stakeholders.Review, approve, and sign Letters of Authorisation (LoA) / Powers of Attorney (PoA) on behalf of Sinclair Group companies.Prepare and manage the Post Market Regulatory budget for the EBD division, ensuring all activities are costed and included; attend budget reviews and monitor expenditures.Approve requisitions for all Post Market Regulatory expenditures within the relevant ERP.To act as lead Regulatory reviewer and approver for all Sinclair Group Distribution Agreements (DA) and Technical Agreements (TA).To prepare, maintain, and present monthly reports and slide decks to communicate Post Market Regulatory status, risks, and issues to the Senior Leadership team and the wider Sinclair Group.To interact with regulatory consultants, trade associates, and other third-party service providers to ensure requested activities are completed within agreed timescales.Maintain all Post Market Regulatory submission documents, shared drive folders, and databases accurately and promptly to ensure access to company regulatory information.Identify and participate in appropriate training events and activities for personal development in regulatory affairs; promote training events to the Post Market Regulatory Team.Review and approve product artworks and partner marketing materials according to applicable regulations.What you bring:University Degree and/or Higher Degree in a related field.More than 6 years’ experience in Regulatory Affairs.Experience with Electrical Based Devices.Fluency in written and spoken English and Spanish; any additional language is welcomeExperience working with partnersRegulatory Affairs Expertise: The ideal candidate should possess a deep understanding of global regulatory legislation and guidelines, particularly within the medical devices sector. Regulatory expertise in global regulations (APAC, MEA, LATAM) is essential for managing compliance and authorizations across diverse regions.Leadership and Team Management: proven experience in leading and managing regulatory teams, both in-person and remotely. Strong leadership skills are crucial for guiding the team to align with Sinclair’s strategic regulatory goals.Strategic Planning and Project Management: strong background especially in developing and executing regulatory strategies. The ability to manage multiple projects under tight deadlines is vital.Communication and Stakeholder Management: Exceptional communication skills are key, as the role involves interacting with internal and external stakeholders, including senior leadership and external partners. Building and maintaining strong relationships will be critical for successful regulatory outcomes.Attention to Detail and Compliance Focus: A high level of attention to detail is required for reviewing and preparing documentation, with a strong focus on compliance with regulatory requirements. Precision in this area is essential to avoid costly errors or delays.Problem-solving, Resolutive, and Thinking Outside the Box to quickly devise innovative solutions to challenges as they arise.Desirable: Knowledge of EU and US regulatory legislation and guidelines would be an advantage.Desirable: Specific knowledge in dermatology/aesthetics would be an asset.Key Skills: Ability to manage a team both face-to-face and remotely.Knowledge of regulatory legislation and guidelines.Knowledge of RoW regulations.Well-organised, target-orientated, and flexible.Ability to work under pressure to tight deadlines in a multidisciplinary environment.Management of confidential information.Excellent attention to detail when reviewing and preparing documentation.Ability to support project teams and management with registrations.Establish and maintain relationships with local affiliates and partners.General Competencies:Orientation towards achievementAdaptability and openness to changeAbility to learnIntegrity and professional ethicsCross-disciplinary cooperationWhat We OfferA competitive salary that matches your knowledge and experience.Medical + Dental Insurance.Hybrid work model.Flexible schedule + short Friday.Fruit at the office.Enjoyable, dynamic, and international environment.This is an exciting opportunity to join a successful company, with big ambitions for the future.If this sounds like you and you meet the requirements, please apply, we would love to hear from you.We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability, and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development, and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.Please note if we receive a high volume of applications, we may close the role before the closing date noted.By making this application you give consent for personal information to be used in automated decision making processes relating to key job requirements which are stated in this ad.If you have any questions, please email recruitment@sinclair.com.Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void.