About the Role
We are seeking an experienced Regulatory Affairs Manager to ensure compliance with international legislation, regulations, and quality standards.
This role is integral to achieving and maintaining market access for our products globally while supporting the delivery of safe and effective devices.
Key Responsibilities
* Develop and execute regulatory strategies with cross-functional teams to meet business objectives and address emerging regulatory challenges.
* Maintain up-to-date knowledge of domestic and international regulatory requirements, sharing updates with internal stakeholders.
* Create and manage high-quality technical documentation, including technical files, design dossiers, and regulatory submissions.
* Serve as the company’s Person Responsible for Regulatory Compliance (PRRC), overseeing technical documentation, post-market surveillance, vigilance reporting, and declarations of conformity.
* Represent the company during external inspections and audits and ensure audit readiness.
* Support quality management system (QMS) maintenance to meet relevant standards, including ISO 13485, 21 CFR 820, and EU MDR.
* Deliver internal regulatory training and support internal audits.
* Collaborate on premarket regulatory strategy and product development to ensure compliance, including risk assessments, biocompatibility, and clinical evaluations.
* Act as the company’s representative in global regulatory environments, engaging with customers, notified bodies, and regulatory authorities.
Key Performance Indicators
* Successful transition to MDR compliance.
* Maintenance of global approvals and licenses.
* Effective processes to maintain state-of-the-art compliance.
Qualifications & Experience
* 6-8 years of regulatory experience, including at least 2 years in a managerial or leadership role.
* Experience in the medical device industry is essential.
* Knowledge of working with certification bodies (e.g., TUV SÜD).
* Expertise in MDR compliance is strongly preferred.
* Relevant qualifications in law, medicine, pharmacy, engineering, or a related scientific field.
* Professional experience with regulatory affairs or QMS in medical devices.
* Desirable: Lead auditor training and management qualifications.
Personal Attributes
* Strong leadership and interpersonal skills.
* Passion for quality, delivery, and continuous improvement.
* Excellent communication and negotiation skills.
* Analytical mindset with attention to detail.
* Independent decision-making and problem-solving abilities.
Working Environment
* Primarily office-based with flexibility for remote working.
* Willingness to travel nationally and internationally as required.
What We Offer
* Opportunity to shape regulatory strategies and make a significant impact on global compliance efforts.
* A collaborative and supportive working environment.
* Professional growth opportunities within a dynamic industry.
How to Apply
Submit your CV and a cover letter detailing your suitability for the role. Applications will be reviewed on a rolling basis.
Join us in ensuring the highest standards of compliance and quality for life-changing medical devices!