Regional Regulatory Affairs Manager

Proclinical is seeking a Regional Regulatory Affairs Manager for a global medical device company, this RA position will be based in Singapore on a permanent basis. This position will represent the Regulatory Affairs function in project teams, and manages regulatory projects to established timelines and budgets. Oversees and ensures compliance with International medical device regulations and overall regulatory departmental objectives, specializing in ASEAN countries. Develops, prepares, and maintains domestic and international regulatory filings and documentation to meet corporate objectives.

Job Responsibilties:

• Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
• Maintain up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidelines and ensure effective communication to the project teams and management.
• In conjunction with international regulatory partners (internal and external) and Regulatory Management, develop, justify, and document sound regulatory strategies to support corporate goals in identified regions globally.
• In collaboration with the international regulatory team, manage interactions with international agents and distributors to clearly identify regulatory requirements and changes on an ongoing basis.
• Directly interact with regulatory bodies internationally in a respectful, professional manner to ensure projects remain on track and issues are identified and resolved as expediently as possible.
• Assign and oversee completion of prioritized tasks to Regulatory Affairs specialists as appropriate.
• Review and approve document change orders (DCOs), technical documents, test protocols and reports, risk management documents, and other documents as a key member of the project teams.
• Manage the preparation and maintenance of high quality filings to clearly documented, established timelines, including but not limited to: Letters to File (LTFs); investigational use applications and annual reports; marketing applications and annual reports to US and international regulatory authorities.
• Manage query resolution process using sound project management skills and to agree upon timelines in collaboration with cross-functional technical teams.
• Coordinates with RA international staff and internal support staff to support basic file preparation as needed.
• Update departmental procedures
• Prepare high quality presentation materials and training materials to meet project objectives and for internal and external communication.
• Perform other duties as assigned by Regulatory Affairs Sr. Management.
• Up to 30% travel is anticipated

Skills and Requirements:

• Minimum bachelor's degree in a scientific discipline or equivalent.
• Minimum 7 years of experience with a Bachelor's degree, 5 years of experience with a Master's degree of directly relevant experience in Regulatory Affairs
• Experience in Regulatory Affairs with US Class III cardiovascular devices strongly preferred.
• Strong interpersonal skills including ability to interact with high degree of diplomacy.
• Good project management skills.
• Extensive knowledge of global medical device regulations and product development processes.
• Comprehensive knowledge of quality systems and relationship to business.
• Experience in developing and communicating global regulatory strategies
• Provide leadership, creativity, and business acumen when interpreting regulatory standards and guidances.
• Ability to work in a fast-paced, technically challenging environment where drive is critical to success
• Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities
• Expertise in Microsoft Office applications and charting programs.
• Effective problem-solving techniques
• Excellent applied thinking and technical writing skills
• Strong communication and organization skills required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mandy Fang on +65 6499 7144 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.