Job Description

The Role

We are currently recruiting for a Regulatory Compliance Manager based in Europe.

The Regulatory Compliance Manager examines, evaluates and investigates eligibility for or conformity laws and regulations governing licenses, approvals and permits by performing inspections and analysis of activities not classified elsewhere. The Regulatory Compliance Manager will play a crucial role ensuring the business operations are executed within ethical boundaries set by the government and industry regulations to identify and alleviate regulatory- associated risks. The Regulatory Compliance Manager is tasked with staying abreast of changes in regulations, interpreting their implications for the organisation and developing and implementing policies and procedures to ensure adherence. They will work closely with cross functions and leadership to assess risks, monitor regulatory developments and implement controls to mitigate regulatory-related risks. The Regulatory Compliance Manager will report to the Global Regulatory Compliance Director.

This role is considered at any of our locations within Europe.

About Sinclair

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.

Our Vision

Providing aesthetic excellence globally.

Our Mission

Driving the advancement of product quality and customer satisfaction, investing in innovation and people.

Our Values

Act with Integrity

Results driven

Innovation centred

One company, one goal

Own it!

Key Responsibilities

Create and maintain regulatory policies, standards, and procedures to ensure compliance across global regions

Ensures the organization adheres to regulatory requirements and internal policies by assessing and managing risks, determining potential regulatory compliance issues and developing strategies to mitigate them

Strategic and department level initiatives focused on improving regulatory compliance

Liaise with all relevant departments to ascertain current compliance levels

Support the business by assisting with compliance risk assessments against the global pharmaceutical regulations

Maintenance of all global site licenses

Act as company PRRC (Person Responsible for Regulatory Compliance) for EU based companies

Conduct regular regulatory audits in all required areas to ascertain compliance levels

Implement regulatory compliance improvement plans where required

Keep up to date with industry standards.

Maintain regulatory, process and product knowledge to provide internal and external audit support

Complete gap analyses for compliance with additions and changes to the standards, rules, and regulations and assesses potential organizational impact.

Develop and/or updates to policies and procedures whenever additions and changes to standards, rules, or regulations warrant

Acts as a liaison internally and with external collaborators for programs

and processes to meet regulatory reporting requirements

Your Skills & Experience - Do You Have What it Takes?

Essential

Minimum 5 years' experience in Regulatory Affairs compliance Global Management within a Medical Device and/or Aesthetics organization

Working knowledge of European Medical Device Regulations

Knowledge of other regulatory legislation and guidelines, e.g.

Global regulations (US, Canada, APAC, LATAM)

Excellent attention to detail when reviewing and preparing documentation

Organized, target-orientated, flexible, good time management skills

Strong written and oral communication skills

Fluency in written and spoken English

Up to 50% Travel

Desirable

University Degree

Proven people leader in a regulated environment

Specific knowledge in dermatology/aesthetics

Working knowledge of Pharmaceutical and Biologic Regulations

Performance-driven critical thinker

with strong business acumen

Ability to coordinate and prioritize multiple demanding tasks in a fast-paced environment

Ability to work effectively in a team environment and build strong working relationships

A bit about you - do you fit this description?

Role competencies:

Personal responsibility

Communication, impact and influence

Analytical and critical thinking capacity

Time management, organization and planning

General competencies:

Orientation towards achievement

Adaptability and openness to change

Ability to mentor and learn

Integrity and professional ethics

Cross-disciplinary cooperation

What We Offer

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.

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.

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.

Job Type: Full-time

Additional pay:

Bonus scheme
Benefits:

Company pension Cycle to work scheme Employee discount Employee mentoring programme Health & wellbeing programme Private medical insurance Referral programme Work from home
Schedule:

Monday to Friday
Experience:

Medical devices: 5 years (required) Global Regulatory Compliance: 5 years (required)
Work Location: Remote