Regulatory Affairs Manager
hace 1 semana
The Regulatory Affairs Manager will act as Sanitary Responsible and Technovigilance representative on behalf of Sinclair Mexico and being responsible for overseeing local regulatory and quality activities in Mexico.
The Regulator Manager will achieve agreed targets and schedules in order to maintain current/ obtain new authorisations/registrations related to company products for Mexico & other LATAM markets in compliance with all relevant regulatory legislation and guidelines.
Location:
Vito Alessio Robles 130, Florida, Alvaro Obregon 01030, Ciudad de Mexico CDMX, Mexico
About Sinclair
Our people embody being the best, mirroring our product and industry values to be the very best versions of themselves.
Sinclair exists to create confidence Confidence in our products, for our customers and of course, for our people.
Our business is on a journey to become the dominant player in strategic global locations, rivalling our competition with diverse product development, by 2026.
Founded 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.
The Role
- Acting as Sanitary Responsible and taking responsibility for Quality system activities for Sinclair Mexico.
- To act as point of contact for COFEPRIS on behalf of Sinclair Mexico and the Sinclair Group.
- To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory and quality legislation and guidelines for devices and establishments in Mexico and other LATAM markets as required.
- Acting as Technovigilance representative providing support to Sinclair Group concerning interpretation and implementation of vigilance requirements and assist with vigilance cases as required.
- To support corporate postmarket regulatory team with, and input into, regulatory strategies for Mexico and LATAM markets.
- Communicate to management any changes in regulations or requirements that have been identified, and complete gap assessments of applicable documents, as required.
- To ensure all authorisations / registrations related to established products are maintained
- Prepare and submit to COFEPRIS final registration packs for all products manufactured by Sinclair Group.
- Monitor pending submissions to ensure timely approvals. Communicate to management any identified delays that may impact business expectations.
- To interact with regulatory consultants, regulatory and trade associates, and other thirdparty service providers to ensure their provision of any requested activities to agreed timescales.
- To provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities.
- Provide official texts for, and review and approve product artworks according to the applicable regulations.
- Ensure maintenance of all submission documents, shared drive folders, and databases in an accurate, complete, and timely manner to ensure prompt and accurate access to company regulatory information.
- Develop and mentor junior colleagues, ensuring that their work is completed to the highest standard and is inline with company expectations & market requirements.
- To identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs.
- As required provide input into budgeting review with reference to Mexico & LATAM markets.
- Maintain monthly business reports as necessary.
- Act as SME for Mexico, providing technical / regulatory input to change control Reg Assessments (RoW)
Your Skills & Experience - Do You Have What it Takes?
Essential:
- University Degree and/or Higher Degree in a scientific field.
- More than 5 years' experience in Regulatory Affairs and Quality Assurance.
- Experience of working with ISO 13485 or equivalent.
- Experience of managing medical device registration in Mexico and working with COFEPRIS directly.
- Excellent computer skills.
- Fluency in written and spoken English. Any additional language is welcome.
- Experience of working with partners.
Desirable:
- Experience of acting as Sanitary Responsible and Technovigilance representative is preferred.
- Specific knowledge in dermatology/aesthetics would be an asset.
A bit about you do you fit this description?
Role competencies:
- Customer focus
- Personal responsibility
- Communication, imp
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