Staff Regulatory Affairs Specialist

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.