Develop regulatory submissions for domestic and international medical device clearances. Support daily regulatory activities related to medical device product design teams, change control, and product submissions. Duties include:

1. Serve as the regulatory lead on cross-functional medical device product development teams to achieve business goals;

2. Prepare domestic and international regulatory submissions to obtain medical device clearances, with a focus on US, Australia, and Japan;

3. Develop regulatory strategies for Japan regarding how to interact and negotiate with the Pharmaceuticals and Medical Devices Agency (PMDA) to obtain medical device clearances;

4. Evaluate international public policies with a direct impact on domestic and international medical device regulations;

5. Advise executive stakeholders on product development and regulatory policy enforcement for international market expansion;

6. Review and revise product labeling and promotional materials to ensure consistency with regulatory approvals;

7. Review and approve R&D, quality, preclinical, and clinical documentation for regulatory submission filings;

8. Provide department support during internal and external regulatory audits;

9. Develop and revise department SOPs to ensure compliance with applicable global regulatory requirements;

10. Stay up-to-date on regulations in product submissions as well as on regulatory topics involving the FDA, PMDA, and Therapeutic Goods Administration (TGA).

Minimum Requirements:  

A Master’s degree or foreign equivalent in Regulatory Affairs, Health Policy, Bioengineering/Biology, or a related field plus 3 years of post-baccalaureate experience in a regulatory affairs specialist-related occupation. If qualifying based on Master’s degree, experience may be gained before, during, or after Master’s program.  

In the alternative, employer will accept a Bachelor’s degree or foreign equivalent in Regulatory Affairs, Health Policy, Bioengineering/Biology, or a related field followed by 5 years of post-baccalaureate experience in a regulatory affairs specialist-related occupation.

Experience must include the following, which may have been gained concurrently:

1) 3 years of experience in the medical device industry handling Class II or higher medical devices;

2) 3 years of spine or orthopedic regulatory submission experience;

3) 3 years of experience with FDA or PMDA Quality System Requirements (QSRs), ISO 13485, or MDD 93/42/EEC;

4) 3 years of experience with technical writing for regulatory and for Quality System Requirements (QSRs)-related documents;

5) 3 years of experience representing the Regulatory Affairs Department on development core teams to ensure products meet the appropriate country requirements during design;

6) 3 years of experience creating submission packages for Japan, liaising with team to ensure country requirements are met to achieve approval(s);

7) 3 years of experience interpreting PMDA device regulations to ensure that the devices meet the PMDA requirements;

8) 1 year of experience reviewing changing trends and updates to MHLW regulations and guidance documents to ensure all product designs meet the PMDA regulations.