About the company

Our client is an established B2B medical aesthetics group with around 30 years in the market. It develops and manufactures hyaluronic acid injectables in-house at its own plant in Spain, alongside chemical peels, mesotherapy and cosmetic products, and sells in more than 80 countries.

- Portfolio: CE-marked Class IIa and Class III medical devices plus cosmeceuticals, sold under its own brands.
- Business model: own brands plus a contract development and manufacturing (CDMO) offer for HA-based medical devices.
- Certifications: ISO 13485 and ISO 22716 (cosmetics GMP).
- Ownership: backed by a European private equity investor, with a growth plan built on new markets, product innovation and targeted M&A.;

The role You will lead regulatory strategy for the company's Class III injectable portfolio and be the company's main counterpart to its notified body. Dermal fillers sit at the strictest end of the EU MDR, so this role directly protects the CE certificates the business depends on.

The timing matters. The business is entering new markets, launching new products and pursuing acquisitions with private equity backing. Each of those needs a regulatory lead who can plan submissions, defend technical documentation in audits and assess the regulatory position of products and companies it may acquire.

This is a hands-on senior role in a mid-sized manufacturer: you shape the strategy and also write, review and sign off the key documents yourself.

Key responsibilities

- Set and run the EU MDR regulatory strategy for Class III and Class IIa devices, including dermal fillers covered by Annex XVI and its common specifications.
- Own the relationship with the notified body: plan and lead conformity assessments, technical documentation reviews,



surveillance and unannounced audits, and answer deficiency questions.
- Prepare and maintain technical documentation (Annex II and III), including the GSPR checklist, risk management file (ISO 14971) and labelling and IFU.
- Work with clinical and R&D; on clinical evaluation reports, PMCF plans and reports, and the Summary of Safety and Clinical Performance (SSCP).
- Lead post-market surveillance outputs: PSURs, vigilance reporting, field safety corrective actions and trend reporting.
- Act as, or closely support, the Person Responsible for Regulatory Compliance (PRRC) under MDR Article 15.
- Manage EUDAMED registrations, UDI and Basic UDI-DI assignment.
- Plan and support registrations in new markets outside the EU, working with distributors and local regulatory agents.
- Assess regulatory impact of design, supplier and manufacturing changes, and approve change controls with Quality.
- Support CDMO customers with the regulatory part of contract manufacturing agreements and technical files.
- Run regulatory due diligence on acquisition targets and lead integration of acquired product portfolios.
- Build and coach the regulatory team as the business grows.

What you bring

Must have

- 8+ years in medical device Regulatory Affairs, with at least 5 years on Class III or implantable devices.
- Direct, first-hand experience with notified bodies:



you have led a Class III conformity assessment or MDR recertification and handled audit findings yourself.
- Strong working knowledge of EU MDR 2017/745, including Annex XVI, MDCG guidance, clinical evaluation and PMS requirements.
- Hands-on authorship of technical documentation, risk management files and clinical evaluation input.
- Working knowledge of ISO 13485 and ISO 14971 in a manufacturing environment.
- Degree in life sciences, pharmacy, chemistry, biomedical engineering or similar; qualifies as PRRC under MDR Article 15.
- Fluent English; able to defend a regulatory position with auditors and senior management.

Nice to have

- Experience with dermal fillers, hyaluronic acid products or other injectable aesthetics.
- Non-EU registrations, for example FDA (PMA), UK MHRA, Brazil ANVISA, Saudi SFDA or China NMPA.
- Regulatory due diligence or integration work linked to M&A.;
- Knowledge of the EU Cosmetics Regulation 1223/2009 for the cosmetic and peel portfolio.
- CDMO or contract manufacturing experience.
- Spanish or Catalan.

What's on offer
- A senior role with direct influence on the company's growth, product launches and acquisitions.
- Ownership of a high-profile, growing Class III portfolio.
- A private equity-backed business investing in R&D;, new markets and its team.
- A base on the Mediterranean coast in Catalonia, Spain.
- Salary and benefits: details shared in a first conversation.

How to apply This search is handled by Panda International, a specialist life sciences recruitment partner. The client's name is shared in a first, confidential conversation. Contact Sandro Canelas Alves, Managing Consultant, at [email protected].

📌 RA specialist - Medical Devices (Barcelona)
🏢 Panda International
📍 Barcelona