Job description:

JOB DESCRIPTION (JOB REF. ID: 45201)

Job responsibilities:

» Manage regulatory affairs for the organization including new product registrations, product notifications, product variation applications and transfer of product licenses in Asia Pacific region where the organization has its activities in

» Obtain timely renewal of product licenses and maintain registration database

» Ensure appropriate licensing, regulatory, marketing and legal compliance of products in each country with the support of local regulatory/distribution partner

» contact with regulatory bodies and distribution partners in the region to maintain product licenses to allow sales activities in these countries

» Ensure product labels and materials are compliant with regulatory requirements

» Collaborate with Global RA team, active communicate across departments and coordinate with distributors and regulatory consultants to achieve timely application submission

» Provide training on regulatory and quality topics when necessary

» Ensure compliance of local government requirements and responsible for QMS maintenance and update for entity e.g. Good distribution and practices for medical device.

» Responsible for quality review and batch test reports for quality release

» Responsible for internal audits across entities and external audits with warehouse partners, manufacturing suppliers

» Lead for outsourcing projects where tech transfers, quality audits and preparation of dossiers are necessary working with key stakeholders in Quality and regulatory departments of suppliers and respective local requirements

» Provide regulatory strategies for new products and any changes in targeted markets

Requirements:

» Possess significant Degree with at least 10 years of Regulatory Affairs/Quality Assurance practice working for medical device companies

» Possess knowledge of regulatory guidelines and requirement of countries in Asia Pacific as well as Quality Management System and GDPMD.

» practice in audits and well verse in requirements on cosmetic GMP, ISO13485 and WHO GMP requirements

All prosperous candidates can expect a very competitive remuneration package and a comprehensive range of benefits.

Interested candidates may wish to email your resume in a detailed Word format to [email protected]

We regret that only shortlisted candidates will be notified.

Please be informed that the personal data you provided by way of your job application to People Profilers will be collected, used and disclosed by or on behalf of People Profilers to determine or investigate your suitcapability, eligibility or qualifications for employment with People Profilers and/or its’ Clients and manage your application for employment with People Profilers and/or its’ clients, including identifying you as a potential candidate for future appropriate positions and/or notifying you of any such positions, either existing or in the future.

EA Licence Number: 02C4944

Registration Number: R1110582

Posting Personnel: Lim Soo Yeong, Joanne

100 Beach Road #33-06

Shaw Tower Singapore 189702

Tel: 6594 9895 Fax: 6835 7890

WORK LOCATION

Address -

RECRUITMENT FIRM SNAPSHOT

EA No. 02C4944

Industry Human Resources Management/Consulting

Website http://www.peopleprofilers.com

Facebook Fan Page https://www.facebook.com/pages/People-Profilers-Pte-Ltd/124869677557849

Company Size 1 - 50 Employees

COMPANY PHOTOS

COMPANY OVERVIEW Since our humble beginnings in 2002, People Profilers has steadily grown from strength to strength. Our skills in providing Human Capital consultancy to our clients – universally sought after skills and skills in just about any sector– has allowed People Profilers to leave an imprint across various industries and build a reputation for competency and skills.

What differentiates People Profilers from every other recruiter is our unwavering commitment to building relationships with our clients- knowledge exactly what our clients are after, and allowing us to match their precise needs. We deliver human capital solutions that allow organisations and their employees to succeed.

Here at People Profilers, we pride ourselves on being a one-stop human capital solutions provider for your organisation. Our innovative and relationship-focused workforce solutions have been provided across a wide variety of industries.

Personal Data Protection Act

Please be informed that the personal data you provided by way of your job application to People Profilers will be collected, used and disclosed by or on behalf of People Profilers to determine or investigate your suitcapability, eligibility or qualifications for employment with People Profilers and/or its’ Clients and manage your application for employment with People Profilers and/or its’ clients, including identifying you as a potential candidate for future appropriate positions and/or notifying you of any such positions, either existing or in the future.

Skills: