Regulatory Affairs Manager (RE-33926859)

Location: Tokyo, Japan
Salary: ¥8000000 - ¥10000000 per annum + competitive
Job Type: Permanent
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<About the Position>

Based in Tokyo office, the person will work closely with the sales and marketing teams to provide daily regulatory support and guidance. The person will routinely conduct reviews of the regulatory bodies and regulations of Japan to advise internal teams on changes, trends, alerts and considerations. When requested, the person will lead or assist in leading regulatory projects in Japan to ensure timely implementation of new or changing standards.

<About the Company>

American based fast-growing and award-winning international medical technology and device company with operations spanning the globe. The company develops innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. By developing revolutionary technologies, the company helps to solve "unsolvable" problems that have plagued the healthcare industry.

<Duties and Responsibilities>

・Exercise independent judgment in determining appropriate regulatory action for new product or product changes and preparation of regulatory documents

・Manage the maintenance of regulatory affairs files (ex. established registrations and device listings, quality certificates, and device licenses)

・Provide guidance and support to other departments(ex. OEM development group) on Japan regulatory and mentor Regulatory Affairs team members

・Support QA and QC in developing and executing compliance activities and corrective actions involving regulatory authorities

・Direct, plan delegate and manage department budget and staff including:

  Hire, promote, demote, reclassify or terminate employees

  Write and conduct performance appraisals and disciplinary actions plans

  Create training and employee development plans

  Handle all departmental employee relations issues

・Prepare and submit Regulatory documentation for medical device applications and ensure timely regulatory clearances

・Interact with regulatory bodies such as MHLW/PMDA

・Work with certified labs on product certification testing

<Minimum Qualifications>

・Bachelor's degree in engineering or Science discipline

・5+ years of RA experience in medical device company, especially approval or certification on submission

・Excellent prioritizing, organizational, collaborative and interpersonal skills

・Maintain alignment with company HQ objectives to ensure efficiency and effective compliance with regulatory and quality initiatives, as well as consistency in business planning across global markets

・Demonstrated ability and experience in liaising with legal counsel, regulatory bodies and agencies to gain required guidance/direction

・Excellent documentation skills including record maintenance/tracking with a strong understanding of document traceability

・Must know regulatory submission requirements for Japanese approval, certification and notification of medical device applications

・Experience in managing team

・Computer Proficiency with MS Office (Word/Excel/ Access/ Outlook)

<Preferred Education/Skills>

・Experience interacting with regulatory bodies such as MHLW/PMDA and the Notified Body

・Willing to travel to US headquarters on a quarterly basis or as needed

Real is part of the larger SThree K.K group

To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com

Award winner of:

Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best Healthcare & Life Sciences Recruitment Company of the Year by Recruitment International Awards 2018

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