Regulatory Affairs Specialist II

ARK Diagnostics, Inc.•Fremont, CA

6d•$95,000 - $115,000•Onsite

About The Position

ARK Diagnostics, Inc. seeking a highly skilled and detail-oriented Regulatory Affairs Specialist II to join our team. In this role, you will be responsible responsible for supporting US/EU/UK/ROW device listing/registration, regulatory assessment of product or process changes, regulatory submission of marketing applications and activities related to new and on-market products meant to ensure compliance with local and international regulatory requirements. The Regulatory Affairs Specialist II plays a supportive role by partnering across business functions to identify data and prepare documentation needed for regulatory clearance, product registration and license maintenance of products worldwide. The ideal candidate for this role will have a degree in a life sciences field such as biology, chemistry, or biomedical engineering and at least 2 years of experience in regulatory affairs in the medical device industry. You will also have excellent communication skills and the ability to work effectively in a collaborative team environment. If you are looking for an exciting opportunity, we encourage you to apply!

Requirements

BS/MS in the Life Sciences, Biomedical Engineering, Regulatory Affairs, or equivalent discipline.
At least 2 years of relevant experience in domestic and international Regulatory Affairs Medical Device industry, preferably with In-Vitro Diagnostics (IVD); Assays is a plus.
Sound knowledge of U.S. and European/International Regulatory requirements and Quality System Standards, as applied to Medical Devices (especially IVDs) => 21 CFR § 820, ISO 13485, ISO 14971, MDSAP, IVDD and IVDR (EU) 2017/746
Experience with international product registrations, license renewals and /or permits.
Experience working directly with notified bodies, authorized representatives and/or international regulatory authorities.
Attention to Quality at every stage of the product life cycle.
Excellent organization and prioritization skills.
Effective communication skills, both written and oral.
Ability to think critically, assess risks, produce creative solutions.

Nice To Haves

Experience with FDA Regulatory submission pathways, such as 510(k), desirable
Regulatory Affairs Certification (RAC), desirable

Responsibilities

Responsible for international regulatory-related request(s) including but not limited to product registration, licensing, permits and/or renewal(s).
Coordinate the market expansion activities with ARK business partners/distributors in various geographies.
Support the preparation of Regulatory documents for new product market clearance, compile content for International Regulatory submissions to sustain product lifecycle including, but not limited to, 510(k), De Novo, and IVDR technical documentation files for CE-marking, Pre- and Post-Market Notifications, CLIA Categorizations, Supplements, Change Notifications, and country-specific product registrations.
Support the timely dissemination of international regulatory requests and/or information to applicable authorized representatives, distributors, customers, as deemed appropriate.
Support senior staff with post-market safety and surveillance activities, product recalls, corrections, if applicable.
Ensure appropriate maintenance of policies, procedures, processes, and practices to comply with US and international regulations regulatory requirements, under the guidance of senior staff.
Responsible for the upkeep and maintenance of all regulatory affairs documentation/files for guidance and reference.
Assist with the review of product labeling, promotional, and advertising materials.
Support internal and external quality and regulatory audits.
Provide senior staff support for training activities for cross-functional teams on various regulatory topics and processes.
Support cross-functional product development teams and other projects, as necessary.