Manager of Regulatory Affairs

Summary:

The position will focus primarily on the creation, preparation, and coordination of regulatory

submissions and approvals to introduce new products in international markets in addition to the

US and EU. The individual must have a good understanding of domestic and international

regulations. Prior international regulatory submissions experience a must. This position will

coordinate the activities and personnel in the regulatory department.

The individual must possess the ability to work independently, and prioritize and use innovative

thinking. Management experience is required. Flexibility and being a team player are required.

Excellent organizational, communication, and computer skills are also essential.

Job Responsibilities:

1. Understand regulatory requirements and relevant government regulations

2. Prepare document packages for regulatory submissions, including Shonins, FDA 510(k), IDE,

PMA(S), STED, Design Dossiers, and Device License Applications.

3. Direct interaction with various regulatory agencies, and/or interactive cooperation with in

country associates and/or consultants to accomplish product clearances.

4. Ability to handle multiple projects with competing timelines

5. Participate on development teams and communicate regulatory requirements for product

development

6. Review and approve test protocols and reports to support regulatory submissions.

7. Review device labeling and advertising materials for compliance with submissions and

applicable regulations; analyze and recommend appropriate changes.

8. Organize and maintain RA documentation and collaterals.

9. Assist in developing systems to improve regulatory efficiency and improve quality.

Qualifications:

1. Bachelor’s degree in a technical field preferred. Technical degree defined as engineering, life

sciences or related medical/scientific field. Advanced degree preferred.

2. Thorough knowledge of Japanese Medical Device Regulations. Thorough knowledge of

European Medical Device Directive and of applicable guidance documents (MEDDEV,

NBMED, etc.) Working knowledge of FDA medical device regulations, guidance, and exports

requirements.

3. Able to manage complex problems/projects by exercising independent decision making and

analytical thinking skills, with general supervision

4. Strong written and oral communications skills

5. Strong organizational and interpersonal skills

6. Excellent computer skills including: MS Office

7. Previous management experience

8. 7-10 years of industry experience