Regulatory Affairs Manager

Contract: Permanent Full-Time

Closing Date: 15/11/24

G&L Healthcare Advisors is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work - and we are rapidly growing Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.

We are excited to offer an opportunity for a Senior Consultant in Medical Devices to provide expert guidance across a range of medical devices and combination products.

You will join an international team of experienced regulatory professionals managing diverse global projects for a wide variety of clients—from major pharmaceutical companies to niche biotech firms.

Each day as a consultant brings new challenges, making this role ideal for someone who thrives on complexity, enjoys client interaction, and excels at navigating intricate regulatory strategies.

**Compensation**: Competitive basic salary + Benefits including healthcare, enhanced pension, bonus, paid sabbatical.

**The Role**:
**Key Responsibilities**:

- Leading regulatory strategy and submission processes for medical devices and combination products, ensuring compliance with MDR, IVDR, and other regulations.
- Providing regulatory expertise in the development of companion diagnostic projects, from early development stages to product launch.
- Advising clients on regulatory requirements for Laboratory Information Management Systems (LIMS), ensuring data integrity and system validation meet current standards.
- Preparing and submitting regulatory dossiers for combination products that integrate medical devices and pharmaceuticals.
- Ensuring compliance with global regulatory frameworks, including FDA, EMA, and other international authorities.
- Providing guidance on post-market surveillance and risk management for medical devices.
- Leading regulatory efforts throughout the product lifecycle, from R&D to commercialization, across various device types.
- Collaborating with cross-functional teams, such as R&D, Quality Assurance, and Marketing, to provide strategic regulatory insights.
- Staying current on global regulatory changes to ensure all client projects meet evolving compliance requirements.

**Requirements**:

- At least 5 years of experience in Regulatory Affairs, specifically within the medical device industry.
- In-depth knowledge of MDR, IVDR, and experience with FDA submissions.
- Expertise in combination products and companion diagnostics.
- Understanding of LIMS regulatory requirements and validation processes.
- Familiarity with regulatory compliance across different medical device classes (I, II, III).
- Strong project management skills, with the ability to manage multiple projects with competing priorities.
- Ability to deliver clear, actionable regulatory advice throughout the product development lifecycle.
- Excellent written and verbal communication skills, with a collaborative approach to working with teams and clients.

**Desirable Skills**:

- Experience with Software as a Medical Device (SaMD).
- Knowledge of global market entry strategies for medical devices.
- Familiarity with regulatory processes in emerging markets.

**How to Apply**:
**Why Join Us?**
- Opportunity to work on cutting-edge medical device projects across diverse fields.
- Collaborative and innovative environment with opportunities for professional growth.
- Competitive salary and benefits package.
- Flexible working arrangements (remote/hybrid).

If you are a highly skilled and versatile Regulatory Affairs professional looking for an exciting role with diverse challenges, we would love to hear from you

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse.

All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.