Senior Regulatory Affairs Specialist

Sinclair; California (MO); Remote; USD 117,000 - 143,000; Full time

Job summary

A leading global medical aesthetics organization is seeking a Senior Regulatory Specialist to manage regulatory activities for product lifecycle. This remote role, preferably based in California, involves ensuring compliance with regulations and supporting global markets. Ideal candidates will have experience in regulatory affairs and strong communication skills.

Benefits

Medical, dental and prescription drug program

Retirement 401k Program

Paid vacation and Sick days

Qualifications

• 3-5 years’ experience in Regulatory Affairs.
• Knowledge of Regulatory legislation and guidelines for medical devices.

Responsibilities

• Provide expert knowledge on regulatory legislation.
• Prepare and submit regulatory applications on time.
• Maintain authorizations and registrations for products.

Skills

Regulatory legislation

Communication

Attention to detail

Teamwork

Critical thinking

Education

University Degree in a scientific or engineering field

Job description

Direct message the job poster from Sinclair

Sinclair are currently recruiting for a Senior Regulatory Specialist for the USA.

The Senior Regulatory Specialist is responsible for the regulatory activities in supporting the lifecycle management for products at Sinclair. The Senior Regulatory Specialist supports a variety of responsibilities and requirements within the organization to achieve agreed targets and schedules to maintain and obtain new and current authorizations and registrations for company products. They will also support global markets as part of the Regulatory team.

Location: Remote with a preference of being based in California

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
• One company, one goal
• Own it!

Key responsibilities

• To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for Sinclair products.
• Communicate to management any changes in regulations or requirements that have been identified
• Undertake the preparation and submission of all new regulatory applications (e.g. clinical trials, registrations, renewals, variations, labelling / artwork) to agreed timelines
• Ensure all authorizations / registrations related to established products are maintained
• Monitor pending submissions to ensure timely approvals. Communicate to management any identified delays that may impact business expectations
• Interact with regulatory consultants, regulatory and trade associates and other third-party 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
• Review and approve product artworks and marketing material according to the applicable regulations
• Maintain 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
• Identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs
• Liaise with and assist vigilance team with respect to vigilance requirements of product dossiers and post marketing activities where necessary
• Maintain monthly business reports as necessary
• Raise purchase orders as necessary and manage invoices related to assigned work.
• Assist in maintenance of tracking spreadsheets of costs for budgeting purposes.
• Organise consular services and translation services.
• Provide technical / regulatory input to Change Control Regulatory Assessments (RoW) and associated RCN / RFRI.
• Work with in-country distributors or contractors to determine regulatory requirements for product registrations in responsible regions.

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

• University Degree in a scientific or engineering field, desirable but not essential.
• 3-5 years’ experience in Regulatory Affairs
• Good in written and spoken English and regional languages as applicable.
• Knowledge of Regulatory legislation and guidelines for medical devices.
• Excellent computer and administration skills.
• Experience of working in an office environment and with both internal and external suppliers/customers.
• Working knowledge of Pharmaceutical and Biologic Regulations
• Performance-driven critical thinker
• 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?
• Well-organised, target-orientated and flexible.
• Ability to work under pressure to tight deadlines in a multidisciplinary environment.
• Ability to complete work with minimal supervision.
• Strong written and oral communication skills.
• Management of confidential information.
• Excellent attention to detail when reviewing and preparing documentation.
• Ability to support project teams and management
• Establish and maintain relationships with local affiliates and partners
• Orientation towards achievement
• Adaptability and openness to change
• Ability to mentor and learn
• Integrity and professional ethics
• Cross-disciplinary cooperation

What We Offer

• Medical, dental and prescription drug program
• Retirement 401k Program
• Paid vacation and Sick days

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 [e-mail].

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Product Management, Science, and Research

• Industries

  Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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Inferred from the description for this job

401(k)

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