Sr Manager, International Regulatory Affairs
1 month ago
Description
:Hydrafacial is hiring a Sr. Manager, International Regulatory Affairs, who is a key contributor in bringing the company’s products into new markets and spearheading global medical device/cosmetic regulatory submissions. Serves as the internal subject matter expert for international regulatory affairs on assigned projects/regions, including labeling review.
HERE’S WHAT YOU’LL BE DOING:
Lead all regulatory affairs transactions within region. Assist with the development of regulatory processes to support the region and all other regulatory submissions, approvals, and inspections. Work on multi-functional team to determine the correct regulatory strategy in each market the company operates in. Oversight of the preparation and filing of regulatory documents with the FDA and international regulatory bodies; setting the standards for and reviewing all submissions to assure adequacy and accuracy. Communication with representatives of foreign regulatory agencies as needed to advance projects. Manage global trade compliance to support customs clearances. Work closely with internal and external clinical affairs experts to review clinical study protocol and management of studies to support regulatory submissions, data integrity and promotional claims. Keep abreast of changes in the global regulatory regulation landscape and communicate those changes to all stakeholders. Additional duties as assigned by management.HERE’S WHAT YOU’LL BRING TO THE ROLE:
8+ years of combined regulatory affairs experience in the medical device industry, both domestically and internationally. Experience in all regulatory processes and regulations in APAC and EMEA market. Cosmetics experience is a plus. Medical device and quality disciplines required. Bachelor’s degree; preferably in a scientific or engineering discipline. Experience with requirements for international product registration. Ability to both understand and write technical documentation is required. Good command in English is fundamental. Every person here is a key player in our success. We are firm believers in making the little things count each day so that the big things will follow. If this sounds like you, come check us out This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.
We mean it when we say you’ll LOVE this role.
BeautyHealth is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, sex, religion, sexual orientation, national origin, gender identity, gender expression, age, disability, genetic information, pregnancy or any other protected characteristic as outlined by color, federal, state or local laws. We are committed to working with and providing accommodation to applicants with physical and mental disabilities.
We have other current jobs related to this field that you can find below
-
Senior Regulatory Affairs Manager
2 weeks ago
Shanghai, Shanghai, China FrieslandCampina Full timeJoin Our Team as a Regulatory Affairs Specialist at ABC Nutrition Company Undergraduate degree or above in food or a related field Over 6 years of regulatory experience in a leading global nutrition company Extensive knowledge of relevant regulations Strong written and oral communication skills with the ability to present to senior executives Why...
-
Senior Regulatory Affairs Manager
4 weeks ago
Shanghai, China FrieslandCampina Full timeWhat we ask Undergraduate degree or above in food or related area. Over 6 years of regulatory experience in a global leading nutrition company. Extensive knowledge of regulations relevant to the area of expertise. Excellent written and oral communication skills as well as demonstrated ability to present to senior level internal and external...
-
Assistant Manager, Regulatory Affairs
4 days ago
Shanghai, China L'Oréal Full timeManage APAC regulatory compliance projects on both cosmetic ingredient and finished product to support R&I innovations. Develop robust compliance solutions with cosmetic, chemical and other possible related area regulatory expertise, risk assessment and recommendation, to both upstream and downstream innovation projects led by APAC R&I hubs and coming to...
-
Sr. Manager-Government Affairs
2 weeks ago
Shanghai, Shanghai, China Lilly Full timeWe're looking for people who are determined to make life better for people around the world. Primary Function/Purpose This role's primary responsibility will be to work closely with all parts of company's China business to maintain/develop strong relationships with key government stakeholders in central government include MOFCOM, NMPA and CNIPA etc....
-
Sr. Manager-Government Affairs
3 weeks ago
Shanghai, China Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Primary Function/Purpose This role’s primary responsibility will be to work closely with all parts of company’s China business to maintain/develop strong relationships with key government stakeholders in central government include MOFCOM, NMPA and CNIPA...
-
Senior Manager, Policy
4 weeks ago
Shanghai, China Pfizer Full timeJob Title: Senior Manager, Policy & Public Affairs China Location: Shanghai, China Reports To: Director of Policy and Public Affairs, PPA Local team Position Summary This position is responsible for Pfizer’s in-market engagement with the local government authorities in North China, to shape Pfizer’s operating environment, form...
-
HGRAC Affairs Manager
4 weeks ago
Shanghai, China Amgen Full timePurpose / Accountabilities •HGRAC Compliance Oversight capability set up and monitoring system functions •SOP, Training and Process update for new implementation rules, regulations and management system updates •Collaborate with LST/CST on HGRAC application submissions, including consultation about the regulation requirements and logistic...
-
HGRAC Affairs Manager
2 weeks ago
Shanghai, Shanghai, China Amgen Full timePurpose / Accountabilities•HGRAC Compliance Oversight capability set up and monitoring system functions•SOP, Training and Process update for new implementation rules, regulations and management system updates•Collaborate with LST/CST on HGRAC application submissions, including consultation about the regulation requirements and logistic...
-
HGRAC Affairs Manager
4 weeks ago
Shanghai, Shanghai, China Amgen Full timePurpose / Accountabilities•HGRAC Compliance Oversight capability set up and monitoring system functions•SOP, Training and Process update for new implementation rules, regulations and management system updates•Collaborate with LST/CST on HGRAC application submissions, including consultation about the regulation requirements and logistic...
-
Corporate Affairs Director
4 weeks ago
Shanghai, China Mars Full timeJOB DESCRIPTION Job Description: To advance our purpose of “A Better World for Pets” the Corporate Affairs Head will lead team to build and protect corporate reputation of Royal Canin China. This role will develop and implement long-term communication strategy to keep Royal Canin China at top of Pet industry; support brand reputation in full respect...
-
Regulatory Officer
2 weeks ago
Shanghai, Shanghai, China PSI Full timeJob Description Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. Office-based in Shanghai Office Your role: REGULATORY INTELLIGENCE Monitor new regulations/guidelines...
-
Regulatory Officer.
2 weeks ago
Shanghai, China PSI Full timeJob Description Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. Office-based in Shanghai Office Your role: REGULATORY INTELLIGENCE Monitor new...
-
Regulatory Officer
2 weeks ago
Shanghai, Shanghai, China PSI CRO Full timeJob DescriptionJoin our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.Office-based in Shanghai OfficeYour role: REGULATORY INTELLIGENCEMonitor new regulations/guidelines and notify...
-
Regulatory Officer
2 weeks ago
Shanghai, China PSI CRO Full timeJob DescriptionJoin our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.Office-based in Shanghai OfficeYour role: REGULATORY INTELLIGENCEMonitor new regulations/guidelines and notify...
-
Sr. Marketing Director
2 weeks ago
Shanghai, Shanghai, China MSD Full timeJob DescriptionRole Overview: We are seeking a dynamic and experienced Sr. Marketing Director to lead our marketing efforts and drive its continued success. The successful candidate will play a pivotal role in developing and implementing marketing strategies, managing a team, and collaborating cross-functionally to achieve business...
-
Sr. Marketing Director
4 weeks ago
Shanghai, Shanghai, China MSD Full timeJob DescriptionRole Overview: We are seeking a dynamic and experienced Sr. Marketing Director to lead our marketing efforts and drive its continued success. The successful candidate will play a pivotal role in developing and implementing marketing strategies, managing a team, and collaborating cross-functionally to achieve business...
-
Associate Clinical Affairs Manager
2 weeks ago
Shanghai, Shanghai, China Philips Full timeJOB DESCRIPTION Job Title Associate Clinical Affairs Manager Job Description In this role, you have the opportunity to · Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs; · Lead the clinical evaluation projects across the product lines, work...
-
Associate Clinical Affairs Manager
1 week ago
Shanghai, China Philips Full timeJob TitleAssociate Clinical Affairs ManagerJob DescriptionIn this role, you have the opportunity to· Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs;· Lead the clinical evaluation projects across the product lines, work closely with Regulatory...
-
Associate Clinical Affairs Manager
3 weeks ago
Shanghai, China Philips Full timeJOB DESCRIPTION Job Title Associate Clinical Affairs Manager Job Description In this role, you have the opportunity to · Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs; · Lead the clinical evaluation projects across the product lines,...
-
Associate Clinical Affairs Manager
1 week ago
Shanghai, Shanghai, China Philips Full timeJob TitleAssociate Clinical Affairs ManagerJob DescriptionIn this role, you have the opportunity to· Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs;· Lead the clinical evaluation projects across the product lines, work closely with Regulatory team,...
