Vacancy Name
Regulatory Compliance Manager
Vacancy No
VN461
Employment Type
Full-Time
Location
Remote- Any of our European locations
Job Details
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.
Location: 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
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
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.
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
Benefits
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.
Currency
GBP
Duration
Salary Maximum
0.00
Salary Minimum
0.00
Regulatory Compliance Manager
Vacancy No
VN461
Employment Type
Full-Time
Location
Remote- Any of our European locations
Job Details
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.
Location: 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
- Be results driven
- Embrace your winning spirit
- Stay ahead of the game
- One team, one goal
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
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.
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
Benefits
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.
Currency
GBP
Duration
Salary Maximum
0.00
Salary Minimum
0.00